Heart help device, system, and method

ABSTRACT

A medical device for assisting in the maintaining of an opening created in the thoracic diaphragm is provided. The medical device comprises a diaphragm contacting part adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm. A pericardial drainage device for draining a fluid from the pericardium of a patient is further provided. The drainage device comprises a conduit; the conduit comprises a first and second section. At least a portion of the first section is adapted to receive a fluid inside of the pericardium. The second section of the conduit is adapted to be positioned outside of the pericardium of a patient and enable the exhaust of said fluid received from said pericardium through at least a portion of said second section.

TECHNICAL FIELD

A device, system and method for improving the pump function of the heartof a human patient are provided. A method of placing and fixating saidheart help device in a human patient is also provided.

BACKGROUND

Cardiac compression is a known method of assisting a failing heart andhas been used for many years. In its most simple form it is applied onthe chest either manually or using an automatic chest compressiondevice. The external methods are basically simple life-saving methodsand can only be used to alleviate acute heart failures.

However, long lasting heart failure is ever increasing, despite theadvancements in cardiology. Implantable mechanical heart compressiondevices could potentially provide treatment for many patients sufferingfrom a failing heart.

On average a human heart beats 31 million times per year which gives anenormous strain in on any mechanical element that wishes to assist orreplace the natural heart. Therefore it is desirable to have a hearthelp device with few moving parts, and where the moving parts are madeof a durable material. This way the device can operate for a long timewithout needing maintenance. Furthermore these devices place largestrain on the heart, if they contact the heart in the same area theentire time. It would also be preferable to have a fixation device andmethod for fixating said heart help device and occasionally existingmotor, energizing members and control logic.

SUMMARY

A medical device for assisting in the maintaining of an opening createdin the thoracic diaphragm is created. The medical device comprises adiaphragm contacting part adapted to be placed in contact with thethoracic diaphragm and thereby assist in the maintaining of the openingcreated in the thoracic diaphragm. The opening could enable a transferbetween the thorax and the abdomen.

According to one embodiment the diaphragm contacting part is adapted toassist in the maintaining of the opening created in the thoracicdiaphragm by engaging the edges of said opening.

The diaphragm contacting part could according to some embodiments hereinbe a grommet or an element with the equivalent function.

The diaphragm contacting part could further be adapted to be in contactwith the pericardium and thereby also assisting in the maintaining of anopening in the pericardium. This embodiment enables transfer between theabdomen and the pericardium.

According to some embodiments the diaphragm contacting part couldfurther comprise a fixation portion adapted to assist in the fixation ofthe medical device to the thoracic diaphragm. The fixation portion couldbe adapted to enable fixation of the medical device to the thoracicdiaphragm by sutures running through said fixation portion and/or bystaples running through said fixation portion. According to yet anotherembodiment the medical device could further comprise a fixation memberadapted to run through said fixation portion for enabling fixation ofthe medical device to the thoracic diaphragm. The fixation member couldcomprise a first portion adapted to be inserted from a first side of thethoracic diaphragm, through a part of the thoracic diaphragm, and to asecond side of the thoracic diaphragm. The fixation member could furthercomprise a second portion adapted to engage the thoracic diaphragm onthe second side and thereby lock said fixation member to the thoracicdiaphragm. The second portion could according to one embodiment behinged to the first portion.

According to some embodiments the medical device further comprises aforce transferring part. The force transferring part could be adapted totravel through the opening and transfer force between the abdominal sideof the thoracic diaphragm and the thoracic side of the thoracicdiaphragm or the pericardium. The force transferring part could comprisea mechanical element adapted to transfer mechanical force such as atleast one of a rotating force and a translating force and/or aneccentrically rotating force.

The force transferring part could further comprise a conduit adapted totransfer hydraulic or pneumatic force and/or an electric lead adapted totransfer electric energy.

The said diaphragm contacting part could be adapted to at least partlyencircle the force transferring part, when in use. According to someembodiments at least one of the diaphragm contacting part and the forcetransferring part could comprise ceramic material.

The diaphragm contacting part and the force transferring part couldaccording to one embodiment be adapted to contact each other in at leastone contacting point. The at least one contacting point could comprisesceramic material for resisting wear.

According to one embodiment the diaphragm contacting part and said forcetransferring part are adapted to seal against each other, such that thethorax could be adapted to seal from the abdomen in the area of thediaphragm contacting part.

According to yet another embodiment the medical device could furthercomprise a second force transferring part. The first force transferringpart could be adapted to transfer a first type of force, and the secondforce transferring part could be adapted to transfer a second type offorce. The first and second type of force could be a type of forceselected from a group consisting of: hydraulic force, pneumatic force,rotational mechanical force, and translational mechanical force.

According to yet another embodiment the force transferring part couldcomprise a first and second portion. The first portion could be adaptedto be in connection with an operation device and the second portioncould be adapted to be in connection with a heart help device. The forcetransferring part could be adapted to transfer force from the operationdevice to the heart help device.

In the embodiments comprising a conduit, it is conceivable that thefirst and second portion is adapted to be in connection with anoperation device adapted to create hydraulic or pneumatic force. Thesecond portion could be adapted to be in connection with a heart helpdevice.

According to another embodiment the first portion could be adapted to bein connection with a hydraulic pump adapted to create hydraulic force.The medical device could further comprise an injection port forinjecting a fluid to the medical device.

According to one embodiment the first portion is adapted to be inconnection with a pneumatic pump adapted to create pneumatic force.

A medical device system is further provided. The medical device systemcomprises: the medical device according to claim, an operation device,and a heart help device.

According to one embodiment the medical device system further comprisesa fixation member adapted to fixate at least a section of the medicaldevice system to a bone of the patient. The bone could be at least onerib of the patient and/or the sternum of the patient and/or at least avertebra of the patient.

According to yet another embodiment of the medical device system, theheart help device could be adapted to at least partly be placed insideof the pericardium of the patient.

The heart help device according to any of the embodiments could beadapted to compress the heart of the patient. According to otherembodiments the heart help device is an artificial heart valve device.

According to one embodiment the operation device is adapted to createmechanical force, the operation device could comprise a first partcomprising at least one coil, and a second part comprising at least onemagnet. The first and second parts could be operable in relation to eachother by energizing of the at least one coil. The operation devicethereby could create the mechanical force.

The operation device could according to some embodiments comprise aplurality of coils and/or plurality of magnets. The force could becreated by successive energizing of the coils.

The operation device could further comprise an eccentrically rotatingmember adapted to transfer force from said operation device to saidheart help device.

The medical device could further comprise a control unit for controllingthe energizing of the at least one coil.

According to one embodiment the first part comprises a first contactingsurface, and the second part comprises a second contacting surface, andwherein said first and second parts are adapted to abut each other inuse.

According to yet another embodiment the medical device further comprisesan implantable injection port unit, the implantable injection port unitcould comprising a plurality of chambers each comprising a penetratableself sealing membrane adapted to be penetrated by a needle for injectinga fluid into said chamber. The plurality of chambers could eachcomprising wall sections defining the volume of the chamber. At leasttwo could be located on two sides of a shared wall section, and therebyshare the shared wall section.

The shared wall section could be a penetratable self sealing membrane

The plurality of chambers could be a first and second chamber. The firstchamber could comprise at least two wall sections being a penetratableself sealing membrane. One of said at least two wall sections could bethe shared wall section, shared with the second chamber.

The first and second chamber could be aligned such that a needle couldenter said second chamber by first penetrating the two penetratable selfsealing membrane wall sections of the first chamber.

Three of the pluralities of chambers are a first and a second and athird chamber. The first and second chambers could each comprise atleast two wall sections being a penetratable self sealing membrane, andthe first, second and third chambers could be aligned such that a needlecould enter said third chamber by first penetrating said twopenetratable self sealing membrane wall sections of said first chamberand penetrating said two penetratable self sealing membrane wallsections of said second chamber.

The plurality of chambers could according to some embodiments be atleast three chambers, at least four chambers or at least five chambers.According to one embodiment the injection port unit further comprises aplurality of conduits in fluid connection with each of the plurality ofchambers.

A medical device system is further provided, the medical device systemcomprises the medical device according to any of the embodiments herein,an operation device, and a heart help device.

According to one embodiment the medical device system further comprisesa fixation member adapted to fixate at least a section of the medicaldevice system to a bone of the patient.

The fixation member could be adapted to fixate at least a section of themedical device system to the sternum of the patient and/or at least onerib of the patient and/or at least one vertebra of the patient.

The heart help device is according to one embodiment adapted to at leastpartly be placed inside of the pericardium of the patient.

The heart help device is according to one embodiment adapted to compressthe heart of the patient.

According to another embodiment the heart help device is an artificialheart valve device

The operation device could according to one embodiment be adapted tocreate mechanical force, the operation device comprises: a first partcomprising at least one coil, and a second part comprising at least onemagnet. The first and second parts are operable in relation to eachother by energizing of said at least one coil; the operation devicethereby creates the mechanical force.

According to some embodiments the operation device comprises a pluralityof coils and/or a plurality of magnets.

According to yet another embodiment the operation device furthercomprises an eccentrically rotating member adapted to transfer forcefrom the operation device to the heart help device.

The medical device system could further comprise a control unit adaptedto control the energizing of the coils.

According to one embodiment the first part of the operation device couldcomprises a first contacting surface, and the second part could comprisea second contacting surface. The first and second parts could be adaptedto abut each other in use.

A pericardial drainage device for draining a fluid from the pericardiumof a patient is further provided, the drainage device comprising aconduit, the conduit could comprise a first and second section. At leasta portion of the first section is adapted to receive a fluid inside ofthe pericardium, the second section of the conduit is adapted to bepositioned outside of the pericardium of a patient and enable theexhaust of the fluid received from the pericardium through at least aportion of the second section.

According to one embodiment of the pericardial drainage device, thesecond section is adapted to be placed in the abdomen of the patient formoving a fluid from the pericardium of the patient to the abdomen of thepatient.

According to one embodiment the drainage device further comprises animplantable container. The second section of the conduit could beadapted to be in fluid connection with the container.

According to yet another embodiment the medical device system furthercomprises a fibrotic tissue movement structure. The fibrotic tissuemovement structure could be placed between the operation device and theheart help device and be adapted to facilitate movement between theoperation device and the heart help device, when implanted.

According to yet another embodiment the medical device system furthercomprises a respiration movement compensator. The respiration movementcompensator could be placed between the operation device and the hearthelp device for compensating for the movements created by therespiration.

A surgical or laparoscopic method of creating and maintaining an openingin the thoracic diaphragm of a patient is further provided. The methodcomprises the steps of creating an incision in the thoracic diaphragmand thereby creating an opening in the thoracic diaphragm, placing adiaphragm contacting part in contact with the diaphragm, therebymaintaining the opening created in the thoracic diaphragm.

The method could according to one embodiment further comprise the stepsof: placing an operation device on the abdominal side of the thoracicdiaphragm, placing a heart help device on the thoracic side of thethoracic diaphragm, and placing a force transferring part, adapted totransfer force from said operation device to said heart help device, atleast partly in the diaphragm contacting part such that said forcetransferring part can transfer force from said operation device to saidheart help device.

According to some embodiments the method further comprises the methodfurther comprises the steps of: placing an energy supply on theabdominal side of the thoracic diaphragm, placing a heart help device onthe thoracic side of the thoracic diaphragm, and placing an electriclead, adapted to transfer electric energy from said energy supply tosaid heart help device, at least partly in said opening created in thethoracic diaphragm, such that said electric lead can transfer electricenergy from said operation device to said heart help device.

According to one embodiment the step of placing a heart help devicecomprises the step of placing a heart help device adapted to exert aforce on the outside of the heart.

According to yet another embodiment, the step of placing a heart helpdevice comprises the step of placing an artificial heart valve or adevice for operating an artificial heart valve.

A method of assisting the heart of a patient is further provided,according to one embodiment the method comprises the steps of: using anoperation device placed on the abdominal side of the thoracic diaphragmto create a force, transferring the force through an opening created inthe thoracic diaphragm, using a heart help device to receive thetransferred force at the thoracic side of the thoracic diaphragm, andusing the force to assist the heart of the patient.

According to one embodiment of the invention an implantable device forimproving the pump function of the heart of a human patient by applyingan external force on the heart muscle, said device comprising at leastone heart contacting organ, periodically exerting force onto the heartmuscle following the heart contractions and adding force thereto, saidimplantable device adapted to have a drive unit to create kineticmovement to be used by the heart contacting organ, wherein saidimplantable device comprising a fixation device adapted to be mounted ina stable position to human bone allowing said drive unit and kineticmovement to get necessary contra force, wherein said drive unit furthercomprising a respiration movement compensator for compensating for therespiratory movement of the heart in relation to the stable boneposition, wherein said drive unit is adapted to allow a movement tocompensate for the respiratory movement in relation between said heartcontacting organ and said bone.

Said respiration movement compensator may comprise a hydraulic,mechanical or pneumatical construction or a combination thereof, for tocompensate for the respiratory movement.

The respiration movement compensator may comprise at least one of; asuspension involving a compressible cuff of air, for to compensate forthe respiratory movement, a spring suspension, for to compensate for therespiratory movement and a guided movement using only frictionalresistance, for to compensate for the respiratory movement.

In yet another embodiment the drive unit is adapted to be placed atleast partly in the abdomen allowing the heart contacting organ to reachthe heart, for creating said kinetic movement of the heart contactingorgan, wherein preferable said drive unit is adapted to entering fromthe abdomen through the diaphragm muscle.

In another embodiment said fixation device is adapted to be mounted onthe outside of the sternum, wherein said drive unit comprising an armfor passing subcutaneously from the outside of the sternum into theabdomen adapted to hold the drive unit, wherein said drive unit enteringthrough the diaphragm muscle holding said heart contacting organ.

In another embodiment said drive unit further comprising a fibrotictissue movement structure adapted to allow the respiratory movement ofthe heart in relation to the stable bone position, without interferencefrom surrounding fibrotic tissue, when implanted in the body.

The fibrotic tissue movement structure may comprise a bellow allowingmovement without stretching surrounding fibrosis, when implanted.

In yet another embodiment the heart contacting organ can change fromexerting force to a first area of the heart to exerting force to asecond area of the heart, after said implantable device has beenimplanted in said human patient, wherein said at least one heartcontacting organ preferable comprises at least one hydraulic orpneumatic cushion.

In another embodiment the heart contacting organ further comprises amechanical element, adapted to be movable to change the position of saidforce exerted on the heart of the human heart after said implantabledevice has been implanted in the human patient.

The implantable device may include a plate, and wherein said at leastone hydraulic or pneumatic cushion is placed in connection to saidplate, and wherein said plate enables movement of said cushion inrelation to said plate to change the position of said hydraulic orpneumatic cushion and thereby change the position of said force exertedon the heart of the human patient after said implantable device has beenimplanted in the human patient.

The heart assistant device may be adapted to; pass through alaparoscopic trocar in the patient's body and/or pass through an openingin the diaphragm muscle from the abdominal side.

Preferable said drive unit is adapted to supply wireless or magneticenergy and said heart assistant device adapted to receive said wirelessor magnetic energy to cause movements of said heart assistant device.

The heart assistant device may include an energy receiver or energysource adapted to be placed in the abdomen.

The heart assistant device preferable, comprising an electric wireadapted to connect said heart assistant device or drive unit to aninternal energy source, said wire adapted to pass into the right atriumof the heart and further up in the venous blood vessel system, exitingthe blood vessel system in or closer to the subcutaneous area, whereinsaid internal energy source is adapted to be connected to said wire viathe subcutaneous area.

The heart assistant device preferable comprising;

an internal control unit,a sensor sensing physiological electrical pulses or muscle contractionsof the heart,wherein said control unit controls said heart assistant device accordingto the sensed information.

The heart assistant device according to claim 10, wherein said internalenergy source, comprising an internal control unit adapted to transmitenergy pulses to said electrode for achieving heart muscle contractionsand controlling heart contractions, wherein said control unit is adaptedto coordinate the heart assistant device with the heart contractions.

In one embodiment a method of surgically placing an active heartassistant device outside a patient's heart via a laparoscopic thoracicapproach, the method comprising the steps of:

-   -   inserting a needle or a tube like instrument into the thorax of        the patient's body,    -   using the needle or a tube like instrument to fill the thorax        with gas thereby expanding the thoracic cavity,    -   placing at least two laparoscopic trocars in the patient's body,    -   inserting a camera through one of the laparoscopic trocars into        the thorax,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars and dissecting an intended        placement area of the patient's heart,    -   placing the heart assistant device in the placement area in the        thorax as one or more pieces comprising;    -   placing the heart contacting organ affecting the blood stream,    -   placing a drive unit creating kinetic movement to be used by the        heart contacting organ,    -   mounting a fixation device in a stable position to human bone        allowing said drive unit and kinetic movement to get necessary        contra force,    -   placing a respiration movement compensator for compensating for        the respiratory movement of the heart in relation to the stable        bone position, and    -   placing and connecting an implanted energy receiver or an        internal source of energy for powering the heart assistant        device to perform at least one of the following method steps; at        least partly compressing the heart and at least partly relaxing        the heart assistant device to support the heart's pumping        mechanism from the outside thereof.

In another embodiment an operation method for surgically placing anactive heart assistant device in relation to a patient's heart, themethod comprising the steps of:

-   -   cutting the patient's skin,    -   opening the thoracic cavity,    -   dissecting a placement area where to place the heart assistant        device inside in relation to the heart,    -   placing the heart assistant device in the placement area in the        thorax as one or more pieces comprising;    -   placing the heart contacting organ affecting the blood stream,    -   placing a drive unit creating kinetic movement to be used by the        heart contacting organ,    -   mounting a fixation device in a stable position to human bone        allowing said drive unit and kinetic movement to get necessary        contra force,    -   placing a respiration movement compensator for compensating for        the respiratory movement of the heart in relation to the stable        bone position, and    -   placing and connecting an implanted energy receiver or a        internal source of energy for powering the heart assistant        device to perform at least one of the following method steps; at        least partly compressing the heart and at least partly relaxing        the heart assistant device to support the heart's pumping        mechanism from the outside thereof.

In yet another embodiment a method of surgically placing an active heartassistant device in relation to a patient's heart via a laparoscopicabdominal approach, the method comprising the steps of:

-   -   inserting a needle or a tube like instrument into the abdomen of        the patient's body,    -   using the needle or a tube like instrument to fill the abdomen        with gas thereby expanding the abdominal cavity,    -   placing at least two laparoscopic trocars in the patient's        abdomen    -   inserting a camera through one of the laparoscopic trocars into        the abdomen,    -   inserting at least one dissecting tool through one of said at        least two laparoscopic trocars and    -   dissecting and creating an opening in the diaphragm muscle,        -   dissecting an intended placement area of the patient's heart            through said opening,    -   placing the heart assistant device in the placement area in the        thorax as one or more pieces comprising;    -   placing the heart contacting organ affecting the blood stream,    -   placing a drive unit creating kinetic movement to be used by the        heart contacting organ,    -   mounting a fixation device in a stable position to human bone        allowing said drive unit and kinetic movement to get necessary        contra force,    -   placing a respiration movement compensator for compensating for        the respiratory movement of the heart in relation to the stable        bone position, and    -   placing and connecting an implanted energy receiver or an        internal source of energy for powering the heart assistant        device to perform at least one of the following method steps; at        least partly compressing the heart and at least partly relaxing        the heart assistant device to support the heart's pumping        mechanism from the outside thereof.

Alternatively an operation method for surgically placing an active heartassistant device in relation to a patient's heart, the method comprisingthe steps of:

-   -   cutting the patient's skin,    -   opening the abdominal cavity,    -   dissecting and creating an opening in the diaphragm muscle,    -   dissecting a placement area where to place the heart assistant        device through said opening,    -   placing the heart assistant device in the placement area in the        thorax as one or more pieces comprising;    -   placing the heart contacting organ affecting the blood stream,    -   placing a drive unit creating kinetic movement to be used by the        heart contacting organ,    -   mounting a fixation device in a stable position to human bone        allowing said drive unit and kinetic movement to get necessary        contra force,    -   placing a respiration movement compensator for compensating for        the respiratory movement of the heart in relation to the stable        bone position, and    -   placing and connecting an implanted energy receiver or an        internal source of energy for powering the heart assistant        device to perform at least one of the following method steps;        at least partly compressing the heart and at least partly        relaxing the heart assistant device to support the heart's        pumping mechanism from the outside thereof.

The four operation methods above, wherein the step of placing the heartassistant device additionally may comprise the step of:

-   -   supplying kinetic power from said drive unit to said heart        assistant device causing movement of said heart contacting        organ.

The four operation methods additionally may comprise the method step of:

-   -   connecting the drive unit with an implantable energy receiver or        an internal energy source for powering said drive unit.

The operation method for surgically placing a heart assistant device ina patient's heart or blood vessel combining the methods with a thoracicapproach and a abdominal approach is a preferred embodiment.

The operation method, wherein the drive unit further comprising a statorand a rotor adapted to be driving at least a part of the heart assistantdevice with rotational energy is yet another alternative, the methodfurther comprising the steps of:

-   -   placing said stator and rotor in the abdomen or thorax, wherein        said rotor is connecting to said heart assistant device,    -   supplying energy to said stator to rotate said rotor and thereby        causing kinetic energy to be transported to said heart assistant        device.

The operation method may comprise that an opening is performed from theabdomen through the thoracic diaphragm for placing the energy receiveror energy source in the abdomen.

The operation method, wherein said opening is performed in the thoracicdiaphragm, is preferable positioned at the place where the pericardiumis attached to the thoracic diaphragm.

In yet another method the heart assistant device or drive unit is usingenergy, direct or indirect, from an external energy source, supplyingenergy non-invasively, without any penetration through the patient'sskin, for powering the heart assistant device or drive unit.Alternatively said heart assistant device or drive unit is connected toan internal energy source via a cable, the method of placement furthercomprising;

-   -   dissecting and placing a wire connected to the heart assistant        device or drive unit into the right atrium of the heart and        further up in the venous blood vessel system,    -   exiting the blood vessel system in or closer to the subcutaneous        area, such as in the vena subclavia, vena jugularis or vena        brachialis placing an internal energy source in the subcutaneous        area or close thereto or in the thorax or abdomen,    -   supplying from an external energy source energy non-invasively,        without any penetration through the patient's skin, to power the        internal energy source for indirect or direct power the heart        assistant device or drive unit.

The operation method of placement may further comprise;

-   -   placing an electrode in the right atrium or ventricle of the        heart    -   placing the wire to the electrode via the right atrium of the        heart and further up in the venous blood vessel system,    -   exiting the blood vessel system in or closer to the subcutaneous        area, such as in the vena subclavia, vena jugularis or vena        brachialis,        placing an internal control unit in the subcutaneous area or        close thereto or in the thorax or abdomen, the method further        comprising at least one of the following steps;    -   transmitting energy pulses from said electrode for controlling        heart contractions, and    -   coordinating the heart assistant device or drive unit.

In yet another embodiment the operation method of placement furthercomprising;

-   -   placing an electrode in the right atrium or ventricle of the        heart    -   placing the wire to the electrode via the right atrium of the        heart and further up in the venous blood vessel system,    -   exiting the blood vessel system in or closer to the subcutaneous        area, such as in the vena subclavia, vena jugularis or vena        brachialis,        placing an internal control unit in the subcutaneous area or        close thereto or in the thorax or abdomen, the method further        comprising at least one of the following steps;    -   receiving sensor input relating to electrical pulses or muscle        contractions of the heart,    -   coordinating the heart assistant device or drive unit based on        said sensor input.

A method of surgically placing an active heart assistant device outsidea patient's heart via a laparoscopic thoracic approach is furtherprovided by inserting a needle or a tube like instrument into the thoraxof the patient's body. The needle or a tube like instrument is used tofill the thorax with gas thereby expanding the thoracic cavity. At leasttwo laparoscopic trocars can be placed in the patient's body and acamera can be inserted into the thorax through one of the laparoscopictrocars. At least one dissecting tool can be inserted through one ofsaid at least two laparoscopic trocars and dissecting an intendedplacement area of the patient's heart. A heart assistant device can beplaced affecting the blood stream. An implanted energy receiver or aninternal source of energy for powering the heart assistant device can beplaced and connected to perform at least one of the following methodstep of at least partly compressing the heart and at least partlyrelaxing the heart assistant device to support the hearts pumpingmechanism from the outside thereof.

One embodiment discloses a method for surgically placing an active heartassistant device in relation to a patient's heart further provided bycutting the patient's skin and opening the thoracic cavity. A placementarea where to place the heart assistant device inside in relation to theheart is dissected and the heart assistant device is placed in theplacement area in the thorax. Further an implanted energy receiver or ainternal source of energy for powering the heart assistant device can beplaced to perform at least one of the following method steps of at leastpartly compressing the heart and at least partly relaxing the heartassistant device to support the hearts pumping mechanism from theoutside thereof.

Another embodiment discloses a method of surgically placing an activeheart assistant device in relation to a patient's heart via alaparoscopic abdominal approach. The method can further be provided byinserting a needle or a tube like instrument into the abdomen of thepatient's body and using the needle or a tube like instrument to fillthe abdomen with gas thereby expanding the abdominal cavity. At leasttwo laparoscopic trocars can be placed the patient's abdomen, throughone a camera can be inserted. Further, at least one dissecting tool canbe inserted through one of said at least two laparoscopic trocars. Thedissecting tool can be used to dissect and create an opening in thediaphragm muscle and/or to dissect an intended placement area of thepatient's heart through said opening. The heart assistant device isplaced in the placement area in the thorax and an implanted energyreceiver or an internal source of energy for powering the heartassistant device is placed and connected to perform at least one of thefollowing method steps to at least partly compressing the heart and atleast partly relaxing the heart assistant device to support the heartspumping mechanism from the outside thereof.

In a further embodiment, a method for surgically placing an active heartassistant device in relation to a patient's heart can be provided bycutting the patient's skin and opening the abdominal cavity. An openingin the thoracic diaphragm is dissected and created and through saidopening a placement area where to place the heart assistant device isdissected. The heart assistant device can be placed in the placementarea and an implanted energy receiver or an internal source of energyfor powering the heart assistant device can also be placed and connectedto perform at least one of the following method steps of at least partlycompressing the heart and at least partly relaxing the heart assistantdevice to support the hearts pumping mechanism from the outside thereof.

In a further embodiment the method also includes the step of placing theheart assistant device additionally by placing a drive unit for at leastpartly powering the heart assistant device with kinetic movements in thethorax or abdomen area and to supply kinetic power from said drive unitto said heart assistant device causing movement of said heart assistantdevice.

In another method steps can also include the connection of the driveunit with an implantable energy receiver or an internal energy sourcefor powering said drive unit.

In another embodiment the different methods for surgically placing aheart assistant device in a patient's heart or blood vessel is combined.

Another method can also include a drive unit further comprising a statorand a rotor adapted to be driving at least a part of the heart assistantdevice with rotational energy. This method further comprising the stepsof placing said stator and rotor in the abdomen or thorax. Said rotor isconnecting to said heart assistant device to supply energy to saidstator to rotate said rotor and thereby causing kinetic energy to betransported to said heart assistant device.

In one additional method an opening is performed from the abdomenthrough the thoracic diaphragm for placing the energy receiver or energysource in the abdomen. Said opening can be performed in the thoracicdiaphragm at the section of the thoracic diaphragm in which thepericardium is fixated to the thoracic diaphragm.

In one further method the heart assistant device or drive unit is usingenergy, direct or indirect, from an external energy source, supplyingenergy non-invasively, without any penetration through the patient'sskin, for powering the heart assistant device or drive unit.

In one further method said heart assistant device or drive unit isconnected to an internal energy source via a cable. The method ofplacement further comprising the steps of dissecting and placing a wireconnected to the heart assistant device or drive unit into the rightatrium of the heart and further up in the venous blood vessel system,exiting the blood vessel system in or closer to the subcutaneous area,such as in the vena subclavia, vena jugularis or vena brachialis,placing an internal energy source in the subcutaneous area or closethereto or in the thorax or abdomen and to from an external energysource supply energy non-invasively, without any penetration through thepatient's skin, to power the internal energy source for indirect ordirect power the heart assistant device or drive unit.

One method of placement can further comprise the steps of placing anelectrode in the right atrium or ventricle of the heart and to placingthe wire to the electrode via the right atrium of the heart and furtherup in the venous blood vessel system. The blood vessel system is exitedin or closer to the subcutaneous area, such as in the vena subclavia,vena jugularis or vena brachialis. An internal control unit is placed inthe subcutaneous area or close thereto or in the thorax or abdomen. Themethod further comprising at least one of the following steps: toreceive a sensor input relating to electrical pulses or musclecontractions of the heart, to transmit energy pulses from said electrodefor controlling heart contractions or to coordinate the heart assistantdevice or drive unit.

One embodiment disclosed is a heart help device adapted to pass througha laparoscopic trocar in the patient's body.

A further embodiment is a heart help device adapted to pass through anopening in the thoracic diaphragm from the abdominal side of thethoracic diaphragm.

A further embodiment is a heart help device comprising a drive unit forat least partly powering movements of the heart help device. Said driveunit is adapted to supply wireless or magnetic energy and said heartassistant device is adapted to receive said wireless or magnetic energyto cause movements of said heart assistant device.

A further embodiment is a heart help device comprising an energyreceiver or energy source, adapted to be implanted in the abdomen.

A further embodiment is a heart help device comprising an electric wireadapted to connect said heart help device or drive unit to said energysource. Said wire is adapted to pass into the right atrium of the heartand further up in the venous blood vessel system, exiting the bloodvessel system in or closer to the subcutaneous area, wherein saidinternal energy source is adapted to be connected to said wire via thesubcutaneous area.

A further embodiment is a heart help device further comprising aninternal control unit and a sensor sensing physiological electricalpulses or muscle contractions of the heart. Said control unit controlssaid heart help device according to the sensed information.

A further embodiment is a heart help device with an energy sourcecomprising an internal control unit adapted to transmit energy pulses tosaid electrode for achieving heart muscle contractions and controllingheart contractions. The control unit is being adapted to coordinate theheart assistant device with the heart contractions.

Please note that all the embodiments or features of an embodiment aswell as any method or step of a method could be combined in any way ifsuch combination is not clearly contradictory. Please also note that thedescription in general should be seen as describing both an apparatus ordevice adapted to perform a method as well as this method in itself.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments now described, by way of example, with reference to theaccompanying drawings, in which:

FIG. 1 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 2 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 3 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 4 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 5 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 6 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 7 shows an operating device in detail.

FIG. 8 shows an operating device in detail.

FIG. 9 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 10 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 11 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 12 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 13 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 14 shows, schematically, a system for transferring force.

FIG. 15 shows, schematically, a system for transferring force.

FIG. 16 shows, schematically, a system for transferring force.

FIG. 17 shows, schematically, how force is exerted on a heart.

FIG. 18 shows, schematically, how force is exerted on a heart.

FIG. 19 shows, schematically, how force is exerted on a heart.

FIG. 20 shows, schematically, how force is exerted on a heart.

FIG. 21 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 22 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 23 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 24 shows an implantable device for improving the pump function ofthe heart in a frontal view.

FIG. 25 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 26 shows, schematically, a system for transferring force.

FIG. 27 shows, schematically, a system for transferring force.

FIG. 28 shows, schematically, an operating device and a fixating member.

FIG. 29 shows, schematically, a system for transferring force.

FIG. 50 shows a fixation system.

FIG. 51 shows a fixation system.

FIG. 52 shows a fixation system.

FIG. 53 shows a frontal view of the sternum of a human patient, with afixating system applied.

FIG. 54 shows a frontal view of the rib cage of a human patient, with afixating system applied.

FIG. 55 shows a frontal view of the rib cage of a human patient, with afixating system applied.

FIG. 56 shows a frontal view of the rib cage of a human patient, with afixating system applied.

FIG. 57 shows a frontal view of the rib cage of a human patient, with afixating system applied.

FIG. 58 shows a lateral view of the vertebral column of a human patient,with a fixating system applied.

FIG. 59 shows a lateral view of the vertebral column of a human patient,with a fixating system applied.

FIG. 60 shows a frontal view of a part of the vertebral column of ahuman patient, with a fixating system applied.

FIG. 61 shows an implantable device for improving the pump function ofthe heart in a lateral view.

FIG. 62 illustrates a system for treating a disease, wherein the systemincludes an apparatus implanted in a patient.

FIGS. 63-77 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 78 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 1.

FIG. 79 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 80 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 1.

FIG. 81 is a circuit for the arrangement shown in FIG. 62, according toa possible implementation example.

FIGS. 82-88 show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

FIG. 89 a shows a sealed chamber comprising an operating device.

FIG. 89 b shows a sealed chamber for hydraulic use.

FIG. 90 shows a lateral view of a patient when a heart help device isfixated to the sternum of the patient, on the inside thereof.

FIG. 91 shows a lateral view of a patient when a heart help device isfixated to a vertebra of the patient.

FIG. 92 shows a lateral view of a patient when a heart help device isfixated to a rib of the patient.

FIG. 93 a shows a lateral view of a patient when a heart help device isfixated to the sternum of the patient on the inside thereof, in adiaphragm penetrating way.

FIG. 93 b shows a lateral view of a patient when a heart help device isfixated to the sternum of the patient, on the outside thereof.

FIG. 94 shows a lateral view of a patient, when a diaphragm contactingpart is placed.

FIG. 95 shows a lateral view of a patient, when an opening is created inthe thorax of the patient.

FIG. 96 shows a close-up of a diaphragm contacting part maintaining anopening in the thoracic diaphragm.

FIG. 97 a shows an embodiment of a heart help device where force istransferred through the thoracic diaphragm.

FIG. 97 b shows a second embodiment of a heart help device where forceis transferred through the thoracic diaphragm.

FIG. 97 c shows an alternative embodiment of the respiratory movementcompensator.

FIG. 97 d shows an alternative embodiment of the respiratory movementcompensator in a second state.

FIG. 98 shows a second embodiment of a heart help device wheremechanical and hydraulic force is transferred through the thoracicdiaphragm.

FIG. 99 a shows a first embodiment of a multi-chamber injection port forcalibrating elements pressing on the heart.

FIG. 99 b shows a second embodiment of a multi-chamber injection port.

FIG. 99 c shows a hydraulic/pneumatic two chamber system.

FIG. 99 d shows a hydraulic/pneumatic system comprising a selectionvalve.

FIG. 99 e shows a hydraulic/pneumatic closed force transferring chambersystem comprising a selection valve.

FIG. 100 shows an embodiment of a heart help device in which hydraulicforce is transferred through the thoracic diaphragm.

FIG. 101 a shows an embodiment of a diaphragm contacting part in whichthe diaphragm contacting part is adapted to be opened, in an open state.

FIG. 101 b shows an embodiment of a diaphragm contacting part in whichthe diaphragm contacting part is adapted to be opened, in a closedstate.

FIG. 101 c shows an embodiment of a diaphragm contacting part, which isnot possible to open.

FIG. 101 d shows an embodiment of a diaphragm contacting part, insection.

FIG. 102 shows a diaphragm contacting part, with a force transferringmember for transferring of mechanical force placed inside.

FIG. 103 shows a diaphragm contacting part, with two force transferringmember for transferring of mechanical force placed inside.

FIG. 104 shows a diaphragm contacting part, with a force transferringmember creating a sealing with the diaphragm contacting part placedinside.

FIG. 105 shows a diaphragm contacting part, with a force transferringmember for transferring of hydraulic force placed inside.

FIG. 106 shows a diaphragm contacting part, with one force transferringmember for transferring of hydraulic, and one force transferring memberfor transferring hydraulic force placed inside.

FIG. 107 shows a force transferring part for transferring force throughthe thoracic diaphragm.

FIG. 108 a shows a displaceable heart help device in a first perspectiveview.

FIG. 108 b shows a displaceable heart help device in a secondperspective view.

FIG. 109 shows a magnetic operating device in section.

FIG. 110 shows a heart help device comprising a magnetic operatingdevice in a perspective view.

FIG. 111 shows a displaceable heart help device in a first perspectiveview.

FIG. 112 a shows a heart help device adapted to be inserted through anopening in the thoracic diaphragm, in its folded state.

FIG. 112 b shows a heart help device adapted to be inserted through anopening in the thoracic diaphragm, in its unfolded state.

FIG. 113 shows a flow-chart of an operation method for fixation a hearthelp device.

DETAILED DESCRIPTION

The invention will now be described in more detail in respect ofpreferred embodiments and in reference to the accompanying drawings. Allexamples herein should be seen as part of the general description andtherefore possible to combine in any way in general terms. Again,individual features of the various embodiments may be combined orexchanged unless such combination or exchange is clearly contradictoryto the overall function of the device.

The use of ceramic material is conceivable for entire device parts orparts exposed to wear, example of ceramic materials that can be used forthis purpose is: zirconium ceramics or alumina ceramics, partiallystabilised zirconia (PSZ), zirconium dioxide, titanium carbide, siliconcarbide, sialons/silicon aluminium oxynitrides, boron nitride. Theceramic material could further comprise a hydroxy-apatite coating.

FIG. 1 shows an implantable device 1 for improving the pump function ofthe heart H of a human patient by applying an external force on theheart muscle. The implantable device 1 comprises a pump device 3 whichcomprises an operating device 57 that creates movement of a connectingarm 244 in contact with a heart contacting organ 2. The implantabledevice is adapted to be fixated to a structure of the human bodycomprising bone 240. The operating device and occasionally occurringother elements that requires control, are controlled from a control unit176. The control unit 176 could comprise an injection port 910 forcalibrating a fluid level of a hydraulic system, a battery 911 forsupplying energy to the implantable device 1, a wireless transfer system912 for transferring energy and/or information to or from the controlunit from outside of the human body and at least one sensor 913 forsensing a variable of the implantable device 1 or the patient. Thecontrol unit communicates with the pump device 3 and other elements ofthe implantable device 1 through a connecting member 906. However it isalso conceivable that the communication could be wireless.

FIG. 2 shows an implantable device 1 for improving the pump function ofthe heart H of a human patient by applying an external force on theheart muscle. The implantable device 1 comprises a pump device 3 whichcomprises an operating device 57 adapted to create a rotating movementthrough successive energizing coils 14 placed on a first plate 11 whichis displaceable in relation to a second plate 12 comprising magnets 15.The magnetic field created between said coils 14 and said magnets 15create a rotating movement of the second plate 12 in relation to thefirst plate 11. According to this embodiment the operating device is inconnection with a first and second heart contacting organ 2 a,b. Thefirst heart contacting organ 2 a is attached to the second plate 12 andthereby moves in relation to the second heart contacting organ 2 b whichis fixedly attached to the pump device 3. The second heart contactingorgan 2 b serves as a dolly. The first and second heart contactingorgans 2 a,b exerts a force on the heart H from the left and right sidesof the heart H which compresses the heart H and assist the pump functionof the heart H.

FIG. 3 shows the implantable device 1 according to an embodiment wherethe pump device 3 is adapted to exert force on the heart H from theanterior A and posterior P side of the heart H. To enable the pumpdevice 3 to exert force on the heart H from the anterior A and posteriorP side of the heart H the implantable device 1 comprises a connectingarm 244 which attaches the pump device 3 to a fixating member 241 a,which in turn is in contact with a first plate 242 a, which is fixatedto a second plate 242 b of a second fixating member 241 b located on theposterior side of a structure of the human body comprising bone 240. Thefirst and second fixating members clamp the structure of the human bodycomprising bone 240 and thereby create the fixation of the implantabledevice 1. The first heart contacting organ 2 a is attached to the secondplate 12 and thereby moves in relation to the second heart contactingorgan 2 b which is fixedly attached to the pump device 3. The secondheart contacting organ 2 b serves as a dolly. The first and second heartcontacting organs exerts a force on the heart H from the anterior A andposterior P sides of the heart H which compresses the heart H and assistthe pump function of the heart H.

FIG. 4 shows the implantable device 1 in a lateral view where theoperating device 57 comprising a first plate 11 comprising magnets 15, asecond plate 12 comprising coils and a third plate 13 comprising magnets15. The successive energizing of the coils 14 of the second plate 12creates rotational movement of both the first and third plate by themagnetic contact created between the coils 14 and the magnets 15. Themovement is transferred to the heart contacting organ 2 which in turnexerts force on the heart H.

FIG. 5 shows the implantable device 1 in a frontal view where theoperating device 57 comprising a first plate 11 comprising magnets 15, asecond plate 12 comprising coils and a third plate 13 comprising magnets15. The successive energizing of the coils 14 of the second plate 12creates rotational movement of both the first and third plate by themagnetic contact created between the coils 14 and the magnets 15. Thefirst heart contacting organ 2 a is fixated to the first plate 11, andthe second heart contacting organ 2 b is fixated to the third plate 13.The movement is transferred to the heart contacting organs 2 a,b whichin turn exerts force on the right and left sides of the heart H, whichcompresses the heart H and assist the pump function of the heart H.

FIG. 6 shows the implantable device 1 according to an embodiment wherethe pump device 3 is adapted to exert force on the heart H from theanterior A and posterior P side of the heart H. To enable the pumpdevice 3 to exert force on the heart H from the anterior A and posteriorP side of the heart H the implantable device 1 comprises a connectingarm 244 which attaches the pump device 3 to a fixating member 241 a,which in turn is in contact with a first plate 242 a, which is fixatedto a second plate 242 b of a second fixating member 241 b located on theposterior side of a structure of the human body comprising bone 240. Thefirst and second fixating members clamp the structure of the human bodycomprising bone 240 and thereby create the fixation of the implantabledevice 1. The first heart contacting organ 2 a is fixated to the firstplate, and the second heart contacting organ 2 b is fixated to the thirdplate. The movement is transferred to the heart contacting organs 2 a,bwhich in turn exerts force on the anterior A and posterior P sides ofthe heart H, which compresses the heart H and assist the pump functionof the heart H.

FIG. 7 shows the operating device 57 is further detail wherein theoperating device 57 comprises a first part comprising a plate 11 with afirst surface, a second part comprising a second plate 12 having asecond surface and a third part comprising a third plate 13 having athird surface. The first, second and third parts are displaceable inrelation to each other and adapted for rotating movement. The secondplate 12 comprises coils 14 whereas the first and third plate comprisesmagnets 15. The coils can be successively energized, controlled from acontrol unit 176, which creates movement of the first and third platesby the magnetic connection between the coils 14 and magnets 15. Thesurfaces of the first and second plate 11,12 abut each other and is insubstantially constant movement which hinders any growth of scar tissuethat could interrupt the function of the operation device 57. To enablethe operating device to resist the wear that constant movement of theabutting surfaces creates, the plates 11,12,13, or alternatively thesurfaces, needs to be made of a highly durable material. Such a materialcould be a ceramic material, a carbon based material or a metallicmaterial such as titanium or stainless steel. It is further conceivablethat the plates or surfaces is made of a self lubricating material suchas a fluoropolymer, alternatively the surfaces could be adapted to belubricated by means of an implantable lubricating system. Theimplantable lubricating system could be adapted to lubricate the plates11,12,13 or surfaces with a biocompatible lubricating fluid such ashyaluronic acid. A combination of mentioned materials is furtherconceivable. The operating device 57 is according to the embodiment inFIG. 7 adapter for rotational movement, however it is possible that theoperation device is adapted for reciprocating movement.

FIG. 8 shows the operating device 57 is further detail wherein theoperating device 57 comprises a first part comprising a plate 11 with afirst surface, a second part comprising a second plate 12 having asecond surface and a third part comprising a third plate 13 having athird surface. The first, second and third parts are displaceable inrelation to each other and adapted for rotational movement. The secondplate 12 comprises coils 14 whereas the first and third plate comprisesmagnets 15. The coils can be successively energized, controlled from acontrol unit 176, which creates movement of the first and third platesby the magnetic connection between the coils 14 and magnets 15. Theoperating device further comprises a centre axis 17 which guides therotational movement of the operating device 57.

FIG. 9 shows a lateral view of an embodiment where the implantabledevice 1 comprises a pump device 3. The pump device 3 comprises a piston50 adapted for reciprocating movement placed in connection with anoperating device 51 for operating the piston 50. The piston 50 is inturn in contact with a heart contacting organ 2 which in turn is incontact with the heart H of a human patient. The implantable devicecould in FIG. 9 further comprise a second pump device 53, the first andsecond pump devices are adapted to operate on the left and right side ofthe human heart H respectively, however in other embodiments the firstand second pump devices 3,53 could be adapted to operate on the anteriorand the posterior side of the heart H of a human patient. Theimplantable device 1 further comprises a first and second fixatingmember 241 a,b adapted to fixate said implantable device 1 to astructure of the human body comprising bone 240. The fixating memberscomprises a first and second plate 242 a,b which are fixated to eachother using screws. To enable the pump device to resist the wear thatconstant movement of the abutting surfaces creates, affected parts orsurfaces, needs to be made of a highly durable material. Such a materialcould be a ceramic material, a carbon based material or a metallicmaterial such as titanium or stainless steel. It is further conceivablethat parts or surfaces is made of a self lubricating material such as afluoropolymer, alternatively the surfaces could be adapted to belubricated by means of an implantable lubricating system. Theimplantable lubricating system could be adapted to lubricate parts orsurfaces with a biocompatible lubricating fluid such as hyaluronic acid.A combination of mentioned materials is further conceivable. The deviceis in substantially constant movement which hinders any growth of scartissue that could interrupt the function of the device.

FIG. 10 shows a lateral view of an embodiment where the implantabledevice 1 is adapted for exerting force on the anterior and posteriorside of the human heart H. The two heart contacting organs 2 a,b areadapted to exert force on the heart H through the connection with thepiston 50 a adapted for reciprocating movement. According to thisembodiment both the heart contacting organ 2 a and the heart contactingorgan 2 b is hinged 52 to the pump device 3 which enables both heartcontacting organs 2 a,b to move and exert force on the heart H. Toenable the heart contacting organs 2 a,b to exert force on the heart Hfrom the anterior and posterior side of the heart H the pump device 3 isattached to a connecting arm 244 which in turn is connected to the firstfixating member 241 a attached to the first plate 242 a which is fixatedto a structure of the human body comprising bone 240 through theconnection with the second plate 242 b of the second fixating member 241b. The piston 50 a is according to this embodiment a piston adapted tocreate movement in two directions, which enables two heart contactingorgans 2 a,b to be operable by means of only one pump device 3. It ishowever conceivable that the piston 50 a is of a type adapted to createmovement in one direction 50 b in which case two pump devices 3,53 couldbe provided to enable two heart contacting organs 2 a,b to be operable.

FIG. 11 shows a frontal view of the implantable device 1 according tothe embodiment shown in FIG. 5A. The pump device 3 is here adapted toexert force on the heart H from the right and left side of the heart Hthrough the heart contacting organs 2 a,b hinged 52 to the pump device3. The piston 50 a is according to this embodiment a piston adapted tocreate movement in two directions, which enables two heart contactingorgans 2 a,b to be operable by means of only one pump device 3. It ishowever conceivable that the piston 50 a is of a type adapted to createmovement in one direction 50 b in which case two pump devices 3,53 couldbe provided to enable two heart contacting organs 2 a,b to be operable.According to this embodiment the first and second heart contactingorgans 2 a,b presses the heart towards each other which exerts a forceon the heart H improving the pump function of the heart H.

FIG. 12 shows a frontal view of the implantable device 1 according to anembodiment where a piston 50 b is adapted to create movement in onedirection. According to this embodiment the second heart contactingorgan 2 b is hinged 52 to the implantable device 1, and the first heartcontacting organ 2 a is fixedly attached to the implantable device 1.According to this embodiment the second heart contacting organ 2 bpresses the heart towards the first heart contacting organ 2 a whichexerts a force on the heart H improving the pump function of the heartH.

FIG. 13 shows a lateral view of an embodiment where the implantabledevice 1 is adapted for exerting force on the anterior and posteriorside of the human heart H. The second heart contacting organ 2 b ishinged 52 to the implantable device 1, and the first heart contactingorgan 2 a is fixedly attached to the implantable device 1. The piston 50b is adapted to create movement in one direction and operates the secondheart contacting organ 2 b to exert force on the heart H from theanterior and posterior side of the heart through the second heartcontacting organ 2 b pressing the heart H against the first heartcontacting organ 2 a. To enable the exerting of force on the anteriorand posterior side of the heart H the pump device 3 is attached to aconnecting arm 244 which in turn is connected to the first fixatingmember 241 a attached to the first plate 242 a which is fixated to astructure of the human body comprising bone 240 through the connectionwith the second plate 242 b of the second fixating member 241 b.

FIG. 14 shows an embodiment where the implantable device 1 comprises asystem for transferring of force from a remote location R to adistribution location D. The heart contacting organ 2 is a section ofthe force distributing piston 50 which exerts force on the heart H, theforce is transferred via a force transferring system 56, which could bea hydraulic, mechanic or pneumatic force transferring system 56. Theforce is created using an operating device 57, in this embodiment theoperating device 57 is an electric motor, however it is also conceivablethat motor is a hydraulic or pneumatic motor. The force generated by theoperating device is then transferred to an eccentric member 58 whichcreates a reciprocal movement in a second piston 55. The reciprocatingmovement created in the second piston 55 it then transferred through theforce transferring system 56 to the first piston 50 which is placed inreciprocating movement, and in turn exerts force on the heart H throughthe connection with the heart contacting organ 2. The first and secondpistons 50, 55 are protected by a protective layer 54 which is made of aflexible material. The protective layer 54 hinders scar tissue to formin proximity to the moving parts, which could hinder the operation ofthe pistons 50, 55. The operating device 57 and additional parts of thesystem that could require control is controlled through the control unit176, which in turn could be adapted to be wirelessly controlled fromoutside of the human body.

FIG. 15 shows an embodiment where the operating device 57 is anoperating device adapted to create a rotating movement throughsuccessive energizing coils 14 placed on a first plate which isdisplaceable in relation to a second plate comprising magnets 15. Themagnetic field created between said coils 14 and said magnets 15 createsa rotating movement of the second plate in relation to the first plate.A mechanical force transferring member 59 is attached to the secondplate and hinged 60 to the piston 50. The piston in turn comprises theheart contacting organ 2 which exerts force on the heart H through theconnection with the operating device 57. A control unit 176 forcontrolling the operating device is also provided, which in turn couldbe adapted to be wirelessly controlled from outside of the human body.

FIG. 16 shows an embodiment where the operating device 57 is a solenoidadapted to create a reciprocating movement of the piston 50 inconnection with the heart contacting organ 2 to exert a force on theheart H of a human patient. A control unit 176 for controlling theoperating device 57 is also provided, which in turn could be adapted tobe wirelessly controlled from outside of the human body.

FIG. 17 shows, schematically, how a piston 50 housed in a protectivelayer 54 exerts force on the heart H of a human patient through theconnection with a heart contacting organ 2. According to this embodimentthe piston 50 is adapted to create reciprocating movement in twodirections, the movement in the first direction is powered and themovement in the second direction could either be powered of created witha spring placed in relation to the piston 50.

FIG. 18 shows, schematically, how a piston 50 housed in a protectivelayer 54 exerts force on the heart H of a human patient through amechanical force transferring system 59 which comprises a hinged joint60. The mechanical force transferring system comprises a heartcontacting organ 2 which in turn exerts force on the heart of a humanpatient H through the connection with the mechanical force transferringsystem 59 and the piston 50 adapted for reciprocating movement.

FIG. 19 shows, schematically, how two pistons 50 a,b exerts force on theheart of a human patient H from the left and right side of the heart H.Each of the two pistons comprises a heart contacting organ 2 a,b whichexerts force on the heart H to compress the heart H to assist the pumpfunction thereof. According to other embodiments the two pistons 2 a,bcould be adapted to be placed on the anterior and posterior side of theheart H, or be movable to enable postoperative change in the position ofthe force exerted on the heart H.

FIG. 20 shows, schematically, how a piston 50 exerts force on the heartof a human patient through the connection with a heart contacting organ2 a from one side of the heart H. A second heart contacting organ 2 b iffixedly attached to the implantable device 1 and serves as a dolly 61 toenable the implantable device 1 to exert force on the heart H.

FIG. 21 shows a frontal view of an implantable device 1 for improvingthe pump function of the heart of a human patient according to anembodiment wherein the implantable device comprises a pump device 3comprises a rotating member 93 having a rotating centre. A drivingmember 91 is attached to the rotating member 93 and adapted to performan eccentric movement in relation to the rotating center of saidrotating member 93. The driving member 91 is in contact with a heartcontacting organ 2 a,b which in turn is adapted to exert force on theheart H of a human patient. The pump device further comprises anoperating device 57 for operating the driving member 91. The operatingdevice is in connection with the rotating member through a forcetransferring member 92 which for example could be a band, cord or chain.The operating device 57 could be an electric, hydraulic or pneumaticmotor, and could be adapted to be controlled from outside of the humanbody. To enable the pump device to resist the wear that constantmovement of the abutting surfaces creates, affected parts or surfaces,needs to be made of a highly durable material. Such a material could bea ceramic material, a carbon based material or a metallic material suchas titanium or stainless steel. It is further conceivable that parts orsurfaces is made of a self lubricating material such as a fluoropolymer,alternatively the surfaces could be adapted to be lubricated by means ofan implantable lubricating system. The implantable lubricating systemcould be adapted to lubricate parts or surfaces with a biocompatiblelubricating fluid such as hyaluronic acid. A combination of mentionedmaterials is further conceivable. The device is in substantiallyconstant movement which hinders any growth of scar tissue that couldinterrupt the function of the device.

FIG. 22 shows a lateral view of an implantable device 1 for improvingthe pump function of the heart of a human patient according to anembodiment wherein the implantable device comprises a pump device 3comprises a rotating member 93 having a rotating centre. A drivingmember 91 is attached to the rotating member 93 and adapted to performan eccentric movement in relation to the rotating center of saidrotating member 93. The driving member 91 is in contact with a heartcontacting organ 2 a,b which in turn is adapted to exert force on theheart H of a human patient. The pump device further comprises anoperating device 57 for operating the driving member 91. The operatingdevice is in connection with the rotating member through a forcetransferring member 92 which for example could be a band, cord or chain.The operating device 57 could be an electric, hydraulic or pneumaticmotor, and could be adapted to be controlled from outside of the humanbody. To enable the exerting of force on the anterior and posterior sideof the heart H the pump device 3 is attached to a connecting arm 244which in turn is connected to a fixating member 241 which is fixated toa structure of the human body comprising bone 240. According to thisembodiment the first heart contacting organ is fixedly attached to thepump device 3 and serves as a dolly, whereas the second heart contactingorgan is hinged to exert the force on the heart H.

FIG. 23 shows a lateral view of the implantable device 1 described inFIG. 21 where the pump device is adapted to exert force on the heart Hfrom the right and left side of the heart H. The driving member 91 is incontact with an operating device 57.

FIG. 24 shows a frontal view of the pump device 3 wherein both the firstheart contacting organ 2 a and the second heart contacting organ 2 b arehinged to the pump device 3 which enables the heart contacting organs 2a,b to exert force on the heart H, assisting the pump function thereof,from the right and left side of the heart H. The driving member 91 isaccording to this embodiment designed to operate two heart contactingorgans 2 a,b through the connection with the operating device 57.

FIG. 25 shows a lateral view of the pump device 3 wherein both the firstheart contacting organ 2 a and the second heart contacting organ 2 b arehinged to the pump device 3, which enables the heart contacting organs 2a,b to exert force on the heart H, assisting the pump function thereof,from the anterior and posterior side the heart H. The driving member 91is according to this embodiment designed to operate two heart contactingorgans 2 a,b through the connection with the operating device 57. Toenable the exerting of force on the anterior and posterior side of theheart H the pump device 3 is attached to a connecting arm 244 which inturn is connected to a fixating member 241 which is fixated to astructure of the human body comprising bone 240.

FIG. 26 shows, schematically, an embodiment of a pump device accordingto any of the embodiments. An operating device 57 operates a rotatingmember 93 having a rotating centre which is attached to a driving member91 adapted to create an eccentric movement. The driving member is incontact with a pivot 100 which is hinged 101. The pivot could serve as amechanical transmitter of force, or as a heart contacting organ 2adapter to exert force on the heart H of a human patient. The operatingdevice is controlled using a control unit 176 connected to the operatingdevice through a connecting member 906. The operating device could be anelectric, magnetic, hydraulic or pneumatic motor. In any embodimentwhere hydraulics is used an injection port 97 could be provided toenable the calibration of fluid in the hydraulic system. The controlunit 176 could further comprise at least one sensor 98 for sensing avariable of the device, or the patient. Furthermore the control unit 176could comprise a wireless transfer unit 99 for transferring of wirelessenergy and/or information. At least one battery 106 could also beprovided in the control unit.

FIG. 27 shows, schematically, an embodiment of a pump device accordingto any of the embodiments. An operating device 57 operates a rotatingmember 93 having a rotating centre which is attached to a driving member91 adapted to create an eccentric movement. The driving member is incontact with a pivot 100 which is hinged 101 in one end, the other endis in contact with another pivot 103 which is hinged in its other end107. The pivot system that the first and second pivot 100,103 could beused as a mechanical transmitter of force, or said first or second pivotcould comprise a heart contacting organ 2 adapted to exert force on theheart H.

FIG. 28 shows, schematically, an embodiment of a pump device 3, wherethe pump device 3 comprises a fixating member 241 which is adapted tofixate the pump device 3 to a structure of the human body comprisingbone 240. The fixating member is adapted to fixate the pump device 3 toa structure of the human body comprising bone 240 using screws 243.

FIG. 29 shows, schematically, an embodiment of a pump device accordingto any of the embodiments. An operating device 57 operates a rotatingmember 93 having a rotating centre which is attached to a driving member91 adapted to create an eccentric movement. The driving member is incontact with a reciprocating member 104 which is guided by two guidingmembers 105 a,b. The reciprocating member 104 could be used as amechanical transmitter of force, or comprising a heart contacting organ2 adapted to exert force on the heart H.

FIG. 30 shows a frontal view of a human patient according to anembodiment where the implanted device 1 is an LVAD 130 (Left VentricularAssist Device). The LVAD can be fixated to a structure of the human bodycomprising bone 240 according to any of the embodiments described.

FIG. 31 shows a frontal view of a human patient according to anembodiment where the implanted device 1 is an artificial heart device131. The artificial heart device 131 can be fixated to a structure ofthe human body comprising bone 240 according to any of the embodimentsdescribed.

FIG. 32 schematically shows a closed pneumatic or hydraulic implantablesystem for transferring force from a remote location R to a distributionlocation D. The system comprises a first reservoir in the form of afirst bellows 141 in contact with an operating device 57, which in thisembodiment is an operating device comprising coils 14 and magnets 15,which is described in further detail previously. The volume of the firstbellows 141 is affected by the contact with the operating device 57which causes a fluid to be transferred in the fluid connection 142,which in turn affects the second bellows 140 on the distributionlocation. The second bellows could be used as a mechanical forcetransmitter or could be provided with a heart contacting organ 2 forexerting force on the heart of a human patient H. The implantable systemis adapted to allow free flow of fluid between said first bellows 141and said second bellows.

FIG. 33 schematically shows a closed pneumatic or hydraulic implantablesystem for transferring force from a remote location R to a distributionlocation D. The system comprises a first reservoir in the form of afirst piston 144. The volume in the cylinder 147 of the first piston 144is affected by the contact with an operating device which causes a fluidto be transferred in the fluid connection 142, which in turn affects thesecond piston 143 on the distribution location, through the change ofthe fluid volume in the second cylinder 148. The second piston 143 couldbe used as a mechanical force transmitter or could be provided with aheart contacting organ 2 for exerting force on the heart of a humanpatient H. The implantable system is adapted to allow free flow of fluidbetween said first bellows 141 and said second bellows. The system couldbe adapted to operate using pressurized fluid in one direction andvacuum in the other direction, or pressurized fluid in both directions.It is also conceivable that the first an second pistons 143,144 operatesby means of a spring 145 a,b in one direction.

FIG. 34 shows a frontal view of a patient where the remote location R ofthe implantable system for transferring force from a remote location Rto a distribution location D, is located in the abdominal region and thedistribution location is located in connection with the heart H. Theremote location comprises a control unit which in turn could comprise anoperating device 146 a, an injection port 146 b, a battery 146 c and atleast one sensor 146 d for sensing a variable of the implantable systemor the patient.

FIG. 35 schematically shows a closed pneumatic or hydraulic implantablesystem for transferring force from a remote location R to a distributionlocation D. The system comprises a first reservoir in the form of afirst bellows 141 an a second reservoir in form of a second bellows 140.The first and second bellows are connected through a fluid connection142. The fluid connection is adapted to always allow free flow of fluidbetween the first and second reservoir.

FIG. 36 schematically shows a closed pneumatic or hydraulic implantablesystem for transferring force from a remote location R to a distributionlocation D. The system comprises a first reservoir in the form of afirst bellows 141 an a second reservoir in form of a second bellows 140.The first and second bellows are connected through a fluid connection142. The fluid connection is adapted to always allow free flow of fluidbetween the first and second reservoir. The system is operated usingpressurized fluid in one direction and spring force from a spring 145 bin the second bellows in opposite direction.

FIG. 37 schematically shows a closed pneumatic or hydraulic implantablesystem for transferring force from a remote location R to a distributionlocation D. The system comprises a first reservoir in the form of afirst bellows 141 in contact with an operating device 57, which in thisembodiment is an operating device comprising a rotating member 93 havinga rotating centre which is attached to a driving member 93 adapted tocreate an eccentric movement affecting the first bellows. The volume ofthe first bellows 141 is affected by the contact with the operatingdevice 57 which causes a fluid to be transferred in the fluid connection142, which in turn affects the second bellows 140 on the distributionlocation. The second bellows could be used as a mechanical forcetransmitter or could be provided with a heart contacting organ 2 forexerting force on the heart of a human patient H. The implantable systemis adapted to allow free flow of fluid between said first bellows 141and said second bellows 140.

A heart contacting organ 2, for example displayed in the embodimentsabove, could be adapted to change the position of the force exerted onthe heart H of a human patient. This could be done by adjusting theposition of the heart contacting organ 2 in relation to a fixatingmember 241 that fixates an implantable device 1 comprising the heartcontacting organ 2 to a structure of the human body comprising bone 240.The adjustment could be performed by moving a connecting arm which isfixated to the fixating member 241 and the heart contacting organ 2. Theobject of moving the heart contacting organ 2 could be to increase theblood flow to area on which the heart contacting organ 2 exerts force.It could also be to improve the positioning of the heart contactingorgan 2 such that the ability of the implantable device 1 to assist thepump function of the heart H. It could further be to relive the patientof any discomfort that the implantable device 1 might cause him/her.

FIG. 38 shows an embodiment in which the heart contacting organ 2 isattached to a connecting arm 244 in connection with the heart contactingorgan 2 and the fixating member 241. The connecting arm 244 is hinged170 a,b to both the heart contacting organ 2 and the fixating member241. However it is conceivable that the connecting arm 244 is hinged toone of the points 170 a and 170 b and fixedly attached to the other 170a,b respectively. The connecting arm 244 could be adapted to be operableeither manually or powered. The connecting arm could be operable bymeans of an operation device 172 which could be an electric, amechanical, a hydraulic or a pneumatic operating device 172. Theoperating device 172 could be placed in connection with the fixatingmember 241 and could be adapter to be remotely controlled from outsideof the human body using a remote control. It is also conceivable thatthe connecting arm could be manually adjusted during a surgical orlaparoscopic procedure in which case an adjusting member (not shown)could be provided to the implantable device 1. The adjusting membercould be one that is adjustable by means of a surgical tool used in thesurgical or laparoscopic procedure.

FIG. 39 shows an embodiment where the heart contacting organ 2 has beenmoved from the position in which it is placed in FIG. 38. The positionof the force exerted on the heart H is thereby moved.

An alternative approach to moving the position of the force exerted onthe heart is to move elements on the heart contacting organ 2. Theelements could be pistons 173 and/or cushions 171 which could beelectrically, mechanically, hydraulically or pneumatically operated. Thepistons 173 and/or cushions 171 could be adapter to be remotelycontrolled from outside of the human body using a remote control. It isalso conceivable that the pistons 173 and/or cushions 171 could bemanually adjusted during a surgical or laparoscopic procedure. The heartcontacting organ could comprise cushions 171 exclusively, pistons 173exclusively or a mixture thereof.

FIG. 40 shows an embodiment in which multiple cushions 171 are placed onthe heart contacting organ 2. The cushions 171 could be raised andlowered in relation to the heart contacting organ 2 to change theposition of the force exerted on the heart H. FIG. 17C further shows aconnecting arm 244 in connection with an operating device 172 foradjusting the location of the heart contacting organ 2 in relation tothe heart H. The operating device 172 could be electrically,mechanically, hydraulically or pneumatically operated and could beadapter to be remotely controlled from outside of the human body using aremote control. It is also conceivable that the connecting arm 244 couldbe manually adjusted during a surgical or laparoscopic procedure. In theembodiment where the cushions 171 or pistons 173 are hydraulic orpneumatically operated the implantable device could further comprise ahydraulic or pneumatic system (not shown) for changing the volume of thecushion 171 or the volume under the piston 173, by moving a hydraulic orpneumatic fluid to or from the cushion 171.

FIG. 41 shows an embodiment where the heart contacting organ 2 comprisesa cushion 174 that exerts force in the heart H. The cushion 174 can bemoved on the heart contacting organ 2 to change the position of theforce exerted on the heart H. According to this embodiment the heartcontacting organ further comprises a rotational element 175 that rotatesto create the movement of the cushion 174 on the great contacting organ2. The rotational element could be operable manually, electrically,mechanically, hydraulically or pneumatically, and can further be adaptedto be remotely controlled from outside of the human body using a remotecontrol. FIG. 17D further shows a connecting arm 244 in connection withan operating device 172 for adjusting the location of the heartcontacting organ 2 in relation to the heart H. The operating device 172could be electrically, mechanically, hydraulically or pneumaticallyoperated and could be adapter to be remotely controlled from outside ofthe human body using a remote control.

FIG. 42 shows the embodiment according to FIG. 38 when implanted in ahuman body. The heart contacting organ 2 comprising cushions 171 and/orpistons 173 which could be raised and lowered in relation to the heartcontacting organ to change the position of the force exerted on theheart H. The implantable device further comprises a connecting arm 244in contact with the heart contacting organ 2 and an operating device 172for operating the connecting arm 244. The operating device is in contactwith the pate of the first fixating member 242 a that together with thesecond fixating member 242 b fixates the implantable device to astructure of the human body comprising bone 240. The implantable devicefurther comprises a control unit 176 for controlling the heart pumpdevice, the operating device 172 and the cushions 171 and/or pistons 173placed on the heart contacting organ 2.

FIG. 43 shows an embodiment where the heart contacting organ 2 isoperable to change the position of the force exerted on the heart Husing two operating devices 177 a,b the two operating devices could bemechanical, hydraulic or pneumatic devices. The heart contacting organis operable through the connection with the operating device through theconnecting arm 244 hinged to the heart contacting organ and theimplantable device comprising the two operating devices 177 a,b.According to other embodiments the connecting arm 244 is operable usingonly one operating device, in which case that operating device could beadapted for powered movement in two directions, or adapted for poweredmovement in one direction and spring loaded movement in the otherdirection.

FIG. 44 shows the heart H of a human patient H in a frontal view wherein179 indicates the right ventricle which is a possible position forexerting force, and 178 indicates the left ventricle which also is apossible position for exerting force. It is also conceivable that forcecould be exerted on two different sides of the right 179 or left 178ventricle, respectively.

FIG. 45 shows the implantable device 1 according to an embodiment wherea pump device 3 is placed on an adjustment system comprising a firstfixating member 241, a second fixating member 185 and a third fixatingmember 186. The first fixating member 241 is adapter for fixation in astructure of the human body comprising bone 240. The first fixatingmember comprises a first trench wherein the second fixating member 185is adapted to move. The second fixating member 185 in turn comprises asecond trench wherein the third fixating member 186 is adapted to move.The third fixating member 186 comprises a piston 182 which can be raisedand lowered for adjusting the pump device 1 in a third axis. The thirdfixating member comprises a surface 183 to which the pump device 3 canbe fixated. Using said adjustment system the pump device 3 can beadjusted three dimensionally which can change the position of the forceexerted on the heart H. The adjustment system can be operable by meansof an implantable motor, the motor could be an electric, hydraulic orpneumatic motor. The motor could be adapted to be remotely controlledfrom outside of the human body using a remote control. The pump device 3could hence be post-operatively adjusted by the patient or by aphysician. The position of the pump device 3 could be verified from theoutside of the human body using x-ray or ultra-sound.

FIG. 46 shows the adjustable system described in FIG. 17H in a secondposition.

The embodiments for changing the position of the force exerted on theheart H of a human patent described above could easily be combined withany of the embodiments of implantable devices described earlier.

FIG. 47-60 shows the fixation of an implantable device to a structure ofthe human body comprising bone 240. The structure could be the sternum,a part of the rib cage, comprising one or more ribs or a part of thevertebral column comprising at least one vertebra. According to oneembodiment the implantable device 1 is fixated to the structure of thehuman body comprising bone 240 trough a fixating member 241 saidfixating member could comprise a plate 242 which is in contact with thestructure of the human body comprising bone 240. The implantable device1 could also be fixated to the structure of the human body comprisingbone 240 using a second fixating member 241 b which also could comprisea plate 242 b in which in turn could be in contact with the structure ofthe human body comprising bone 240.

FIG. 47 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240. The structure couldbe the sternum, a part of the rib cage comprising one or more ribs or apart of the vertebral column structure comprising at least one vertebra.According to the embodiment the implantable device 1 comprises a firstfixating member 241 a comprising a plate 242 a and a second fixatingmember 241 b comprising a plate 242 b. The first and second fixatingmembers are attached to each other using through-going screws 243 placedfrom the anterior side A of the structure of the human body comprisingbone 240. An alternative embodiment could comprise screws placed fromthe posterior side P of the structure of the human body comprising bone240. The first fixating member 241 a and the second fixating member 241b clamp the structure of the human body comprising bone 240. Thefixating member 241 a could be in contact with a connecting arm 244which in turn could be in contact with a heart pump device.

FIG. 48 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240 using only onefixating member 241 a comprising a plate 242 a. The structure could bethe sternum, a part of the rib cage comprising one or more ribs or apart of the vertebral column structure comprising at least one vertebra.Through-going screws 243 is placed form the anterior side A thestructure of the human body comprising bone 240 and fixated in the plate242 a. An alternative embodiment could comprise screws placed from theposterior side P of the structure of the human body comprising bone 240in which case the screws could be fixated in nuts placed in connectionwith the structure of the human body comprising bone, or fixated indirectly in the bone of the structure of the human body comprising bone240. The fixating member 241 a could be in contact with a connecting arm244 which in turn could be in contact with a heart pump device.

FIG. 49 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240. The structure couldbe the sternum, a part of the rib cage comprising one or more ribs or apart of the vertebral column comprising at least one vertebra. Accordingto the embodiment the implantable device 1 comprises a first fixatingmember 241 a comprising a plate 242 a and a second fixating member 241 bcomprising a plate 242 b. The first and second fixating members areattached to each other using through-going screws 243 placed from theposterior side P of the structure of the human body comprising bone 240.The screws are fixated to nuts 245 placed on the anterior side of thestructure comprising bone 240. An alternative embodiment could comprisescrews placed from the anterior side A of the structure of the humanbody comprising bone 240, in which case the nuts is placed on theposterior side P of the structure comprising bone 240. The firstfixating member 241 a and the second fixating member 241 b clamp thestructure of the human body comprising bone 240. The fixating member 241a could be in contact with a connecting arm 244 which in turn could bein contact with a heart pump device.

FIG. 50 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240 using only onefixating member 241 a comprising a plate 242 a. The structure could bethe sternum, a part of the rib cage comprising one or more ribs or apart of the vertebral column structure comprising at least one vertebra.Screws 243 that fixates the fixating member to the structure of thehuman body comprising bone is placed form the posterior side P thestructure of the human body comprising bone 240. The screws fixates thefixating member to both the posterior and the anterior cortex of thestructure of the human body comprising bone 240, however it isconceivable that the screws are fixated only to the anterior orposterior cortex. An alternative embodiment could comprise screws placedfrom the anterior side A of the structure of the human body comprisingbone 240, in which case the fixating member 241 a is placed on theanterior side A of the structure of the human body comprising bone 240.

FIG. 51 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240 using one fixatingmember 241 b comprising a plate 242 b, and one fixating member 241 awithout a plate. The structure could be the sternum, a part of the ribcage comprising one or more ribs or a part of the vertebral columnstructure comprising at least one vertebra. Screws 243 that fixates thefixating members 241 a,b to the structure of the human body comprisingbone 240 is placed form the anterior side A of the structure of thehuman body comprising bone 240 and fixated in the fixating member 241 a.The first fixating member 241 a and the second fixating member 241 bclamp the structure of the human body comprising bone 240. The fixatingmember 241 a could be in contact with a connecting arm 244 which in turncould be in contact with a heart pump device.

FIG. 52 shows an embodiment where the implantable device 1 is fixated toa structure of the human body comprising bone 240 using one fixatingmember 241 b comprising a plate 242 b, and one fixating member 241 awithout a plate. The structure could be the sternum, a part of the ribcage comprising one or more ribs or a part of the vertebral columnstructure comprising at least one vertebra. Screws 243 that fixates thefixating members 241 a,b to the structure of the human body comprisingbone 240 is placed form the posterior side P of the structure of thehuman body comprising bone 240 and fixated in the plate 242 b of thefixating member 241 b. The first fixating member 241 a and the secondfixating member 241 b clamp the structure of the human body comprisingbone 240. The fixating member 241 a could be in contact with aconnecting arm 244 which in turn could be in contact with a heart pumpdevice.

FIG. 53 shows an embodiment where the implantable device 1 is adapted tobe fixated to the sternum 250 of a human patient. The device is fixatedusing a fixating member 241 b which is fixated to the sternum usingscrews 243. However the implantable device could be fixated to thesternum 250 of a human patent using any of the ways to place thefixating members described previously.

FIG. 54 shows an embodiment where the implantable device 1 is adapted tobe fixated to two ribs 251, 252. A fixating member 241 comprising aplate 242 b is fixated with screws adapted to fixate the fixating memberto the cortex of the ribs.

FIG. 55 shows an embodiment where the implantable device 1 is adapted tobe fixated to two ribs 251, 252. A first plate 242 a is provided on theposterior side of the rib cage, whereas a second plate 242 b is providedin the anterior side of the rib cage. Screws 243 penetrate the ribs andfixates the first plate 242 a to the second plate 242 b. The tighteningof the screws creates a clamping effect of the ribs 251,251 and providesthe fixation of the implantable device 1. In another embodiment (notshown) the screws 243 are placed between the ribs 251,252 and that waysprovides a clamping effect of the ribs 251,252.

FIG. 56 shows an embodiment where the implantable device 1 is adapted tobe fixated to one rib 252. A plate 242 a is provided on the posteriorside of the rib cage and screws 243 are provided from the outsidethereof, penetrating the rib 252 and fixating the plate 242 a to the rib252.

FIG. 57 shows an embodiment where the implantable device 1 is adapted tobe fixated to one rib 252 using cord or band 254, this way there is noneed to penetrate the rib 252. However the implantable device could befixated to the ribcage of a human patent using any of the ways to placethe fixating members described previously.

FIG. 58 shows an embodiment where the implantable device 1 is adapted tobe fixated to a vertebra 255 of the vertebral column. A fixating member241 is fixated to the vertebra 255 using screws 243. The implantabledevice further comprises a connecting connecting arm 244 that connectsthe implantable device 1 to the fixating member 241.

FIG. 59 shows an embodiment where the implantable device 1 is adapted tobe fixated to two vertebras 255, 256 of the vertebral column. A fixatingmember 241 is fixated to the two vertebras 255, 256 using screws 243.The implantable device further comprises a connecting connecting arm 244that connects the implantable device 1 to the fixating member 241.

FIG. 60 shows an embodiment where the implantable device is adapted tobe fixated to a vertebra 255 of the vertebral column by clamping saidvertebra 255. Two fixating members 241 a, 241 b is placed on two sidesof the vertebra and an attachment comprising screws 243 clamps thevertebra between the first and second fixating members 241 a,b. Theimplantable device further comprises a connecting connecting arm 244that connects the implantable device 1 to the fixating member 241.

In all of the above mentioned embodiments the means of attachment couldbe replaced with other mechanical attachments or an adhesive. Othermechanical attachments suitable could be: pop-rivets, nails, staples,band or cord. The mechanical fixating members could be of a metallic orceramic material. Suitable metallic materials could be titanium orsurgical steel.

FIG. 61 shows an embodiment where the heart contacting organ 2 isadapted to compress the heart H to assist the pump function thereof. Astimulation device 907 is attached to the heart contacting organ 2 andis adapted to stimulate the heart H to achieve an additional assistanceof said pump function after the heart contacting organ 2 has placed theheart in the compressed state. According to an embodiment the heartcontacting organ is attached to a connecting arm 244 which in turn isattached to a mechanical, electrical or hydraulic operating device 172which operates the heart contacting organ 2. The operating device 172 isin turn attached a fixating member which fixates the device to astructure of the human body comprising bone 244 using mechanicalfixating members such as screws, or adhesive. A control device 176 forcontrolling the operating device 172 in accordance with any of theembodiments described in this application is in connection with saidoperating device 172 though a connecting member 906. However it is alsoconceivable that the control device 176 communicates wirelessly with theoperating device 172.

FIG. 62 illustrates a system for treating a disease comprising anapparatus 10 placed in the abdomen of a patient. An implantedenergy-transforming device 1002 is adapted to supply energy consumingcomponents of the apparatus with energy via a power supply line 1003. Anexternal energy-transmission device 1004 for non-invasively energizingthe apparatus 10 transmits energy by at least one wireless energysignal. The implanted energy-transforming device 1002 transforms energyfrom the wireless energy signal into electric energy which is suppliedvia the power supply line 1003.

The implanted energy-transforming device 1002 may also comprise othercomponents, such as: a coil for reception and/or transmission of signalsand energy, an antenna for reception and/or transmission of signals, amicrocontroller, a charge control unit, optionally comprising an energystorage, such as a capacitor, one or more sensors, such as temperaturesensor, pressure sensor, position sensor, motion sensor etc., atransceiver, a motor, optionally including a motor controller, a pump,and other parts for controlling the operation of a medical implant.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 63 illustrates the system of FIG. 62 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 64 shows an embodiment identical to that of FIG. 63, except that areversing device in the form of an electric switch 1006 operable forexample by polarized energy also is implanted in the patient forreversing the apparatus 10. When the switch is operated by polarizedenergy the wireless remote control of the external energy-transmissiondevice 1004 transmits a wireless signal that carries polarized energyand the implanted energy-transforming device 1002 transforms thewireless polarized energy into a polarized current for operating theelectric switch 1006. When the polarity of the current is shifted by theimplanted energy-transforming device 1002 the electric switch 1006reverses the function performed by the apparatus 10.

FIG. 65 shows an embodiment identical to that of FIG. 63, except that anoperation device 1007 implanted in the patient for operating theapparatus 10 is provided between the implanted energy-transformingdevice 1002 and the apparatus 10. This operation device can be in theform of a motor 1007, such as an electric servomotor. The motor 1007 ispowered with energy from the implanted energy-transforming device 1002,as the remote control of the external energy-transmission device 1004transmits a wireless signal to the receiver of the implantedenergy-transforming device 1002.

FIG. 66 shows an embodiment identical to that of FIG. 63, except that italso comprises an operation device is in the form of an assembly 1008including a motor/pump unit 1009 and a fluid reservoir 1010 is implantedin the patient. In this case the apparatus 10 is hydraulically operated,i.e. hydraulic fluid is pumped by the motor/pump unit 1009 from thefluid reservoir 1010 through a conduit 1011 to the apparatus 10 tooperate the apparatus, and hydraulic fluid is pumped by the motor/pumpunit 1009 back from the apparatus 10 to the fluid reservoir 1010 toreturn the apparatus to a starting position. The implantedenergy-transforming device 1002 transforms wireless energy into acurrent, for example a polarized current, for powering the motor/pumpunit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 67 shows an embodiment comprising the external energy-transmissiondevice 1004 with its wireless remote control, the apparatus 10, in thiscase hydraulically operated, and the implanted energy-transformingdevice 1002, and further comprising a hydraulic fluid reservoir 1013, amotor/pump unit 1009 and an reversing device in the form of a hydraulicvalve shifting device 1014, all implanted in the patient. Of course thehydraulic operation could easily be performed by just changing thepumping direction and the hydraulic valve may therefore be omitted. Theremote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 1009 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the apparatus 10 to operate theapparatus, and another opposite direction in which the fluid is pumpedby the motor/pump unit 1009 back from the apparatus 10 to the hydraulicfluid reservoir 1013 to return the apparatus to a starting position.

FIG. 68 shows an embodiment comprising the external energy-transmissiondevice 1004 with its wireless remote control, the apparatus 10, theimplanted energy-transforming device 1002, an implanted internal controlunit 1015 controlled by the wireless remote control of the externalenergy-transmission device 1004, an implanted accumulator 1016 and animplanted capacitor 1017. The internal control unit 1015 arrangesstorage of electric energy received from the implantedenergy-transforming device 1002 in the accumulator 1016, which suppliesenergy to the apparatus 10. In response to a control signal from thewireless remote control of the external energy-transmission device 1004,the internal control unit 1015 either releases electric energy from theaccumulator 1016 and transfers the released energy via power lines 1018and 1019, or directly transfers electric energy from the implantedenergy-transforming device 1002 via a power line 1020, the capacitor1017, which stabilizes the electric current, a power line 1021 and thepower line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 7 10 may be omitted. In accordance with another alternative, theaccumulator 1016 in this embodiment may be omitted.

FIG. 69 shows an embodiment identical to that of FIG. 63, except that abattery 1022 for supplying energy for the operation of the apparatus 10and an electric switch 1023 for switching the operation of the apparatus10 also are implanted in the patient. The electric switch 1023 may becontrolled by the remote control and may also be operated by the energysupplied by the implanted energy-transforming device 1002 to switch froman off mode, in which the battery 1022 is not in use, to an on mode, inwhich the battery 1022 supplies energy for the operation of theapparatus 10.

FIG. 70 shows an embodiment identical to that of FIG. 69, except that aninternal control unit 1015 controllable by the wireless remote controlof the external energy-transmission device 1004 also is implanted in thepatient. In this case, the electric switch 1023 is operated by theenergy supplied by the implanted energy-transforming device 1002 toswitch from an off mode, in which the wireless remote control isprevented from controlling the internal control unit 1015 and thebattery is not in use, to a standby mode, in which the remote control ispermitted to control the internal control unit 1015 to release electricenergy from the battery 1022 for the operation of the apparatus 10.

FIG. 71 shows an embodiment identical to that of FIG. 70, except that anaccumulator 1016 is substituted for the battery 1022 and the implantedcomponents are interconnected differently. In this case, the accumulator1016 stores energy from the implanted energy-transforming device 1002.In response to a control signal from the wireless remote control of theexternal energy-transmission device 1004, the internal control unit 1015controls the electric switch 1023 to switch from an off mode, in whichthe accumulator 1016 is not in use, to an on mode, in which theaccumulator 1016 supplies energy for the operation of the apparatus 10.The accumulator may be combined with or replaced by a capacitor.

FIG. 72 shows an embodiment identical to that of FIG. 71, except that abattery 1022 also is implanted in the patient and the implantedcomponents are interconnected differently. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 73 shows an embodiment identical to that of FIG. 69, except that amotor 1007, a mechanical reversing device in the form of a gear box1024, and an internal control unit 1015 for controlling the gear box1024 also are implanted in the patient. The internal control unit 1015controls the gear box 1024 to reverse the function performed by theapparatus 10 (mechanically operated). Even simpler is to switch thedirection of the motor electronically. The gear box interpreted in itsbroadest embodiment may stand for a servo arrangement saving force forthe operation device in favour of longer stroke to act.

FIG. 74 shows an embodiment identical to that of FIG. 73 except that theimplanted components are interconnected differently. Thus, in this casethe internal control unit 1015 is powered by the battery 1022 when theaccumulator 1016, suitably a capacitor, activates the electric switch1023 to switch to an on mode. When the electric switch 1023 is in its onmode the internal control unit 1015 is permitted to control the battery1022 to supply, or not supply, energy for the operation of the apparatus10.

FIG. 75 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters. Theinternal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 76 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the apparatus 10 via a subcutaneous electricswitch 1026. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 77 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 78 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 78 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physical parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 78employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance, such an integratedinformation feedback and energy system comprises an implantable internalenergy receiver for receiving wireless energy, the energy receiverhaving an internal first coil and a first electronic circuit connectedto the first coil, and an external energy transmitter for transmittingwireless energy, the energy transmitter having an external second coiland a second electronic circuit connected to the second coil. Theexternal second coil of the energy transmitter transmits wireless energywhich is received by the first coil of the energy receiver. This systemfurther comprises a power switch for switching the connection of theinternal first coil to the first electronic circuit on and off, suchthat feedback information related to the charging of the first coil isreceived by the external energy transmitter in the form of an impedancevariation in the load of the external second coil, when the power switchswitches the connection of the internal first coil to the firstelectronic circuit on and off. In implementing this system in thearrangement of FIG. 78, the switch 1026 is either separate andcontrolled by the internal control unit 1015, or integrated in theinternal control unit 1015. It should be understood that the switch 1026should be interpreted in its broadest embodiment. This means atransistor, MCU, MCPU, ASIC FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.

To conclude, the energy supply arrangement illustrated in FIG. 78 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system comprises animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a feedback device forcommunicating out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factor between the first and secondcoils. The energy transmitter may regulate the transmitted energy inresponse to the obtained coupling factor.

With reference to FIG. 79, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 79,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 80 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.78, an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 78 and FIG. 80 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope.

FIG. 81 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 81 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatusfrom outside of the patient's body using inductive energy transfer. Aninductive energy transfer system typically uses an external transmittingcoil and an internal receiving coil. The receiving coil, L1, is includedin the schematic FIG. 64; the transmitting parts of the system areexcluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 81and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 81 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 64 could be incorporated in any of theembodiments of FIGS. 67-73, the hydraulic valve shifting device 1014 ofFIG. 67 could be incorporated in the embodiment of FIG. 66, and the gearbox 1024 could be incorporated in the embodiment of FIG. 65. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 78, 80 and 81identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 82-85 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus.

FIG. 82 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 83 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 84 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 85 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 86 a-c. InFIG. 86 a, a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 86 a, the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 86 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 87 and 88 a-c. The block diagramshown in FIG. 87 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 88 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 88 a, the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.86 a-c, the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

FIG. 89 a shows an embodiment of the implantable device, wherein theimplantable device comprises an eccentrically rotating member 891, beinga driving member, being a part of an operation device having a rotatingcentre 803. The operation device further comprises an embodiment of amagnetic motor, such as the magnetic motor described with reference toFIGS. 7 and 8 comprising coils 804 and magnets in magnetic connectionwith said coils 804. The coils 804 are placed on a first plate 812 whichis in connection with a second plate 891 comprising the magnets. In theembodiment shown in FIG. 89 a, the second plate 891 comprises theeccentrically rotating member 891. The first 812 and second 891 platesare adapted to be rotationally displaceable in relation to each other,and a force is created by successive energizing of the coils 804 inmagnetic connection with the magnets, which creates a rotationalmovement of the first plate 812 in relation to the second plate 891which in turn affects the eccentrically rotating member 891. Further,according to the embodiment of FIG. 89 a, the first 812 and second 891plates are adapted to be in contact with each other, in use, in acontacting surface which according to this embodiment comprises ceramicmaterial for resisting wear.

The operation device is placed in a sealed chamber confined by thepiston 801 and the sleeve 802. The piston 801 and sleeve 802 isaccording to this embodiment adapted to be in contact with each otherand to create a seal in a contact point 807. The contact point 807 couldcomprise a ceramic material resistant to wear, which prolongs the lifeof the implantable device. According to the embodiment of FIG. 89 a, theeccentrically rotating member 891 is adapted to create movement of thepiston 808 in a first direction, the movement in the opposite directionis created by spring members 805 which are loaded when the eccentricallyrotating member 891 presses the piston 808 in the first direction. Thepiston 808 could be adapted to be in direct contact with the heart, orto affect an arm or heart contacting organ, which in turn is in contactwith the heart.

FIG. 89 b shows another embodiment of the implantable device, comprisinga piston placed in a sleeve 802. The piston and the sleeve togetherconfines a sealed space adapted to 806 receive a high pressuredhydraulic fluid from an inlet 809. The high pressured hydraulic fluid isadapted to push the piston 801 in a first direction, whereas the vacuumcreated when the hydraulic fluid is sucked from the sealed space 806through the outlet 810. The piston 801 is in contact with the sleeve 802in a contact point 807, here being an area 807 between the sleeve 802and the piston 801. The contacting area 807 could be made from a ceramicmaterial and thereby adapted to better resist the wear that is createdby the implantable device having to operate at the speed of the heart.The hydraulic fluid could for example be pressurized using a hydraulicpump. According to some embodiments the system is a pneumatic system inwhich case the implantable device is powered by a gas compressed by apneumatic pump. In yet other embodiments (not shown) the piston 801 isadapted to be moved in the opposite direction by means of spring members805, much like the embodiment of FIG. 89 a, this could be needed if thepiston 801 and sleeve 802 are very tightly fitted for sealing against avery high pressure since the force exerted by vacuum is limited.

FIG. 90 shows a lateral view of a human patient in section where animplantable device for assisting the heart function is implanted. Theheart H is placed in the pericardium P which is a heart covering sac inwhich the heart H is placed. The pericardium P rests on, and is fixatedto the thoracic diaphragm D separating the thorax from the abdomen. Theimplantable device comprises a connecting arm 244 connecting a heartcontacting organ 2 to a plate 242 fixated to the sternum 250 of thepatient. According to other embodiments the plate 242 or the fixationarm 244 could be fixated to at least one rib of the patient, or at leastone vertebra. According to the embodiment of FIG. 90 the heart helpdevice is a device adapted to compress the heart by exerting a force onthe external part of the heart H, however in other embodiments the hearthelp device could be an artificial heart, or en LVAD device, fixated toa part of the human body comprising bone in the same way.

The heart rests on the superior surface of the thoracic diaphragm D. Thepericardium P is a triple-layered sac that encloses the heart H. Theouter layer being the fibrous pericardium adheres to the thoracicdiaphragm D inferiorly and superiorly it is fused to the roots of thegreat vessels that leave and enter the heart H.

By creating the opening and placing a diaphragm contacting part 501,which according to some embodiments is a grommet, in the area of thethoracic diaphragm D in which the heart H rests it is possible to gainaccess to the pericardium P without actually entering the thoraciccavity outside of the pericardium P. The pressure in the thoracic cavityis somewhat different from the pressure in the abdominal cavity, whichamong other things makes it more advantageous to be able to connect aheart pump device engaging the heart H to an operating device placed inthe abdominal cavity without entering the thoracic cavity outside of thepericardium P.

FIG. 91 shows a lateral view of a human patient in section where animplantable device for assisting the heart function is implanted. Aconnecting arm is fixated to a plate 241 which is fixated to a vertebraof the vertebral column using a screw 243, however alternative means offastening is equivalently conceivable, such as pop rivets, adhesive or afixating wire. The connecting arm is in turn fixating an operatingdevice 57, adapted to operate the heart help device. From the operatingdevice another portion of the connecting member 244, being a forcetransferring member 502 extends forward and upward in the figure. Theforce transferring member 502 is adapted to transfer force from theoperating device 57 to the heart contacting organ 2 placed in connectionwith the heart. The force transferring member 502 transfers forcethrough a diaphragm contacting part 501, in this case being a grommet501 placed in contact with the thoracic diaphragm D and therebyassisting in the maintaining of an opening from the abdominal side ofthe thoracic diaphragm D to the thoracic side of the thoracic diaphragmD. In other embodiments the diaphragm contacting part is excluded andthe force transferring member 502 (or diaphragm passing part) therebytransfers force through the thoracic diaphragm D, passing an opening inthe thoracic diaphragm D without passing through a diaphragm contactingpart

The operation device 57 could be an operation device adapted to create amechanical force, a hydraulic force, a pneumatic force which is thentransferred by the force transferring member 502. In other embodimentsan energy supply such as a battery is placed in the abdomen and fixatedto a part of the human body comprising bone. The electric energy is thentransferred to through an electrical lead passing through the thoracicdiaphragm D through the diaphragm contacting part 501 assisting in themaintaining of an opening in the thoracic diaphragm D. In otherembodiments the electric energy is transferred through an opening in thethoracic diaphragm D through an opening in the thoracic diaphragm Dwithout passing a diaphragm contacting part.

FIG. 92 shows a lateral view of a human patient in section where animplantable device for assisting the heart function is implanted. Aconnecting member 244 connects an operating device 57 to a rib 251 ofthe patient through a fixation plate 242 being fixated to said rib 251.The operating device 57 is in turn adapted to operate a forcetransferring member 502 placed between said operating device 57 and aheart contacting organ 2 adapted to be in contact with the heart H. Theforce transferring member 502 is adapted to transfer force through adiaphragm contacting part 501 placed in the thoracic diaphragm D andassisting in maintaining an opening in the thoracic diaphragm D and thepericardium P. This is further explained with reference to FIG. 91. Thefixation plate 242 is here placed on the outside of the rib 251, howeverit is equally conceivable that the fixation plate 242 is placed on theinside. The fixation plate 242 could for example be fixated to the rib251 using screws which could be adapted to fixate the plate 242 to theouter cortex of the rib 242, the inner cortex of the rib 251, both theinner and outer cortex of the rib 251, or in a through going embodimentwherein the screw thus clamps the rib 251 for example through a nut andbolt arrangement, or a second plate with threads placed on the inner orouter side of the rib 251.

FIG. 93 a shows a lateral view of a human patient in section where animplantable device for assisting the heart function is implanted. In theembodiment of FIG. 93 a a fixation plate 242 is fixated to the inside ofthe sternum 250. A connecting arm 244 is fixated to the connecting arm244 and penetrates the thoracic diaphragm D through a first diaphragmcontacting part 501 b. The connecting arm 244 in turn fixates anoperating device 57 which operates a force transferring member 502 whichin turn transfers force through the thoracic diaphragm D through asecond diaphragm contacting part 501 to the heart help device comprisinga heart contacting organ 2 adapted to be in contact with the heart H ofthe patient. The second heart contacting part 501 assists in themaintaining of an opening in the thoracic diaphragm D and thepericardium P. This is further explained with reference to FIG. 91, andthe diaphragm contacting parts 501, 501 b and force transferring member502 is further described with reference to FIGS. 101-107.

FIG. 93 b shows a lateral view of a human patient in section where animplantable device for assisting the heart function is implanted. In theembodiment of FIG. 93 b a fixation plate 242 is fixated to the outsideor anterior side of the sternum 250. A connecting arm 244 then passesalong the sternum and in to the abdomen of the patient and is bent toextend in to the abdomen to a section of the thoracic diaphragm D inwhich the pericardium P rests and is fixated to the thoracic diaphragmD. From the operating device 57 a force transferring member 502penetrates the thoracic diaphragm D through a diaphragm contacting part501. The heart contacting organ 2 in contact with the heart 2 is a partof a heart help device adapted to assist the pump function of the heartby exerting a force on the external part of the heart. This embodimentenables a fixation of the operating device 57 and the heart help devicein the abdomen without having to enter the thorax outside of thepericardium P. This makes it possible to separate the thorax from theabdomen which, among other aspects, is advantageous since there is adifference in pressure between the thorax and the abdomen.

FIG. 94 shows a surgical or laparoscopic method of creating andmaintaining a opening in the thoracic diaphragm D of a patient. Themethod comprises the steps of: creating an incision 503 in the thoracicdiaphragm D and thereby creating a opening 503 in the thoracic diaphragmD, placing a diaphragm contacting part 501 in contact with the thoracicdiaphragm D, thereby maintaining the opening 501 created in the thoracicdiaphragm D. According to the embodiment of FIG. 94 the opening 503 inthe thoracic diaphragm D is made in the section of the thoracicdiaphragm D in which the pericardium P rests and is fixated, the openingcontinues into the pericardium P of the patient, which create an openingreaching from the abdomen and into the pericardium P enabling an elementto be placed in contact with the heart H through the said opening 503.FIG. 94 further shows a section of a heart help device comprising aheart contacting organ 2, a connection arm 244, a fixation plate 242 anda screw 243 for fixation of the fixation plate 242. The connection arm244 is bent such that said connecting arm 244 is adapted to fixate aheart help device to a part of the human body comprising bone throughthe diaphragm contacting part 501 maintaining an opening in the thoracicdiaphragm D.

FIG. 95 shows a lateral view of a patient showing the heart H beingplaced in the pericardium P in the thorax resting on and being fixatedto a section of the thoracic diaphragm D. FIG. 95 shows a illustrates amethod of placing a heart help device through an incision in the thorax506. The heart help device comprising a fixation plate 242, a connectingarm 244 and a heart contacting organ 2. The operation methods of FIGS.94 and 95 could be performed as surgical methods or laparoscopic methodswhere the steps of the methods are performed through trocars placed inthe thorax and abdomen, respectively.

FIG. 96 shows a close-up of part of the thoracic diaphragm D and thepericardium P in the section of the thoracic diaphragm D in which thepericardium P rests and is fixated. The diaphragm contacting part 501 isassisting in the maintaining of an opening in the thoracic diaphragm Dand the pericardium P. The diaphragm contacting part 501 is a grommetlike structure with protrusions 507 extending from the part of thediaphragm contacting part 501 defining the opening from the abdominalside of the thoracic diaphragm D to the thoracic side of the thoracicdiaphragm D. The protrusions 507 clamps the edges of the opening in thethoracic diaphragm D and the pericardium P and thereby assists in thefixation of the diaphragm contacting part 501 to the thoracic diaphragmD and the pericardium P.

FIG. 97 a shows an embodiment of a heart help device adapted to assistthe pump function of the heart by exert force on the outside of theheart H. The heart H is placed in the pericardium P which rests and isfixated to the thoracic diaphragm D at a section of the thoracicdiaphragm. FIG. 97 a shows an embodiment where an operation device 57 isplaced in the abdomen of a patient. A force transferring member 502comprises a first and second portion. The first portion is connected toan operation device 57 placed in a sealing operation device container518 adapted to protect the operation device 57 from the environment ofthe abdomen. The second portion of the force transferring member 502 isconnected to a force entering section 517 of the heart help deviceplaced in the pericardium P. The force entering section transfers theforce supplied by the force transferring member 502 to two arms 516connected to two force transferring members 502 a and 502 b at apivotable joint 515. The heart contacting organs 502 a,b are adapted tobe in contact with the heart H on the anterior and posterior side of theheart H for exerting force on the heart H to assist the pump functionthereof.

The force transferring part 502 is adapted to transfer force through thethoracic diaphragm D at a section of the thoracic diaphragm D in whichthe pericardium P rests and is fixated to the thoracic diaphragm D. Anopening in the thoracic diaphragm D and the pericardium P is maintainedbe a diaphragm contacting part 501 adapted to be in connection andfixated to the pericardium P and/or the thoracic diaphragm D.

The operating device shown in FIG. 97 a is a magnetic operating devicefurther disclosed with reference to FIGS. 7 and 8, however it is equallyconceivable that the operating device is an electrical motor, a servomotor, a hydraulic motor or a pneumatic motor. The operating devicecould be adapted to create a rotational mechanical force and/or atranslational mechanical force and/or an eccentrically rotatingmechanical force.

FIG. 97 b shows an embodiment of an implantable heart help devicecomprising the elements of the embodiment shown in FIG. 97 a. Theembodiment of FIG. 97 b further comprises a fibrotic tissue movementstructure 560 being a bellows shaped elastic member with protrusions 561and recesses 562 for enabling movement of the force transferring membereven after fibrotic tissue has begun to grow on the fibrotic tissuemovement structure 560 after the implantable device has been implantedin a patient for some time. The fibrotic tissue movement structure 560is fixated to the sealing operation device container 518 placed in theabdomen of the patient, and to the diaphragm contacting part assistingin the maintaining of an opening in the thoracic diaphragm D. The forcetransferring part 502 placed between the heart help device and theoperation device container 518 placed in the abdomen comprises a first563 part in connection with the operating device 57 and a second part564 in connection with the heart help device. The first 563 and second564 part constitutes a respiration movement compensator for compensatingfor the movements in the body created by the respiration of the patient.The respiration movement compensator is extend/compressible through atelescopic functionality. A guide pin 565 is fixated to the first part563 and placed in a groove in the second part 564 and the respirationmovement compensator thereby enabled transfer of torque/rotational forcewhile maintaining the ability to extend/compress for compensating forthe movements in the body created by the respiration of the patient.FIG. 97 b further shows a fixation member comprising a connecting arm244 and a fixation plate 242. The fixation member is adapted forfixating the implantable device to the outside of the sternum or atleast one rib, however, embodiments where the fixation members isadapted to enable fixation of the implantable heart help device to theoutside of the sternum or at least one rib is equally conceivable. Toenable the respiration movement compensation to function the arms 516a,b are pivotably arranged to the diaphragm contacting part 501 andmovable in relation to the operation device container 518.

FIG. 97 b further shows a pericardial drainage device for draining afluid from the pericardium P of a patient. The drainage device comprisesa conduit comprising a first 980 and second 981 section. At portion ofthe first section 980 is adapted to receive a fluid inside of thepericardium P. The second section 981 of the conduit is adapted to bepositioned outside of the pericardium P of the patient and enable theexhaust of the fluid received from the pericardium P through at least aportion of the second section 981.

The pericardial drainage of the embodiment of FIG. 97 b is adapted movea fluid from the pericardium P of the patient to the abdomen of thepatient, however in other embodiments it is equally conceivable that thedrainage device is adapted to move fluid from the pericardium P to anyother location in the body. The second section 981 could be connected toan implantable container 983 for collecting the drained fluid, or anexhaust member for exhausting the fluid into the abdomen of the patient.

FIG. 97 c shows an alternative embodiment of the respiration movementcompensator disclosed with reference to FIG. 97 b. This alternativeembodiment enables movements around a spherically shaped connecting partof the first part 563. The connecting part comprising splines 565adapted to be placed in corresponding splines 566 in the second part 564for enabling the transfer of torque while maintain the ability to movein multiple directions. FIG. 97 d shows the respiratory movementcompensator when the first part 563 is tilted in the second part 564.

FIG. 98 shows the implantable heart help comprising the elements of theheart help device disclosed with reference to FIG. 97 a. The heartcontacting organs 502 a,b of FIG. 98 further comprises hydraulic orpneumatic cushions 171 adapted to exert force on the heart H. Thehydraulic or pneumatic cushions 171 could change to alter the area ofthe heart H to which force is exerted. The cushions comprises chambershaving a volume and the size of that volume is adapted to be changeableindividually, for each cushion to influence the force exerted on theheart H after the implantable heart help device has been implanted inthe patient. The hydraulic or pneumatic cushions have volumes adapted tobe changed using an implantable hydraulic or pneumatic system 519,according to this embodiment adapted to be placed in the abdomen of thepatient. The hydraulic or pneumatic system comprises multiple conduits514, which according to this embodiment separates into two section 514a,b for enabling movement of the cushions 171 of the first and secondheart contacting organ 502 a,b. the hydraulic or pneumatic conduits 514is according to this embodiment adapted to transfer force through anopening in the thoracic diaphragm D adapted to be maintained by adiaphragm contacting part 501. In the embodiment of FIG. 98 thediaphragm contacting part is thus adapted to allow both a mechanicalforce transferring member 502 and a hydraulic pneumatic forcetransferring member to pass through the diaphragm contacting part 501.In other embodiments (not shown) the implantable heart help devicefurther comprises an electric system at least partially adapted to beplaced in the abdomen of the patient and comprising an electric leadadapted to transfer electric energy, an electric control signal orsensor input to or from the part of the implantable heart help deviceplaced in the thorax of the patient. The heart help device according toany of the embodiments herein could further comprise one or more sensors598 providing input. This could in any of the embodiments herein forexample be a signal relating to the heart rhythm, the blood pressure,the blood flow, electric activity of the heart, temperature, time orvariable relating to the content of the blood, such as saturation,sodium, erythrocytes, leukocytes and/or trombocytes. The heart helpdevice according to any of the embodiment herein could further beequipped with at least one electrode supplying an electric signal forcontrolling the heart rhythm, such as a pace maker signal. Theenergizing system or control unit for handling the sensor signals couldbe adapted to be placed in the abdomen of the patient.

FIG. 99 a shows the implantable heart help device in an embodiment wherethe heart help device comprises a hydraulic system for controlling aplurality of hydraulic cushions 171 a-e. The hydraulic system comprisesan implantable injection port unit 527. The injection port unit 527comprising a plurality of chambers 524 a-e each comprising wall sectionsbeing penetratable self sealing membranes 528 a-d adapted to bepenetrated by a needle 529 attached to an injecting member 530 forinjecting a fluid into the chambers 524 a-e. The needle is insertedthrough a insertion guide 526 fixated to human tissue 525 for example bysubcutaneous implantation. The needle is then inserted through one ormore of the wall sections 528 a-d for injecting a fluid into a specificchamber 524 a-e and thereby affect a specific cushion 171 a-e and by theconnection through the conduits 514 a-e. In the embodiment shown in FIG.99 a the plurality of conduits are bundled into a conduit bundle 531.

The location on the needle 529, i.e. in which chamber 524 a-e the fluidis injected could be controlled by a system of sensors that by forexample induction feels the presence of the needle 529 in a specificchamber 524 a-e. The system of sensors could be adapted to wirelesslytransmit the signals to the physician injecting the fluid into thesystem. It is furthermore conceivable that the system comprises sensorssensing the amount of hydraulic fluid injected to specific chambers 524a-e and thereby how much each cushion 171 a-e has been affected.

FIG. 99 b shows an alternative design of the injection port unit asdescribed with reference to FIG. 99 a. The injection port unit here hasthe plurality of chambers 524 a-e placed next to each other and therebythe needle does not have to penetrate several wall portions to reach aspecific chamber 524 a-e.

FIG. 99 c shows an embodiment of a hydraulic system for supplying forceto an implantable heart help device. The hydraulic system comprises acylinder 904 in which a piston 905 is placed such that a first andsecond chamber 906 a,b exists on the two sides of the piston 905. Thepiston 905 is adapted to move in said cylinder 904 in response to thechambers 906 a,b being pressurized using a hydraulic or pneumatic fluidF. The system further comprises a first and second conduit 907 a,b fortransferring the hydraulic or pneumatic fluid F to the two chambers 906a,b.

Two chambers 909 and 910 comprises the hydraulic or pneumatic fluid F.The first chamber 909 is adapted to be a high pressure chamber andadapted to hold a fluid F having a high pressure. The pressure ismaintained by a pressurized gas 911 being confined behind a membrane ofthe chamber and thereby exerting a pressure on the fluid in the chamber909. The fluid is transported to a valve 908 that has two states. In thefirst state of the valve the valve guides the fluid from the first highpressure chamber to the second cylinder chamber 906 b pressing thecylinder 905 upwards in the FIG. In this state the valve also enablesthe fluid from the first cylinder chamber 906 a to be pressed into theconduit 907 a and through the valve and into the low pressure chamber910. The fluid is then pumped to the high pressure chamber 909 using apump 915 placed between a first 913 and second 912 part of a conduit. Acheck valve 914 is further placed on the conduit for enabling thepressure in the high pressure chamber 909 to remain high even when thepump 915 is turned off. At a second state of the valve 908 the fluid isguided from the high pressure chamber 909 through the conduit 907 a andinto the first cylinder chamber 906 a, which thereby pushes the cylinderdownwards in the FIG. The second cylinder chamber is thereby emptied inan a procedure analogue the what was described for the first cylinderchamber 906 a and the fluid is passed to the low pressure chamber 910.The cylinder 905 is connected to a rod 903 transferring the force to aheart contacting organ 902, directly, as disclosed in FIG. 99 c, or viaan intermediary part. The system further comprises an injection port 917for refilling or calibrating the system. The injection port 917 isimplanted subcutaneously and fixated to a tissue of the body 918 andconnected to the low pressure chamber 910 by a conduit 916.

By the function of the system disclosed with reference to FIG. 99 c thesystem can move the cylinder 905 and thereby the heart contacting organ902 using a pressurized fluid F in two directions, which eliminated thelimitation in force that operation by vacuum places on a system.

FIG. 99 d shows a hydraulic system with similar functionality as thesystem of FIG. 99 a. A high pressure chamber 909, comprising a gaspressure 911, presses a fluid F, which is in contact with a valvethrough a conduit 921. The valve 920 is adapted to direct the fluid to aplurality of conduits 919 in connection with a plurality of pistons 922in connection with a heart contacting organ, for changing the area ofthe heart in which force is exerted, the pistons being placed on a plate923.

99 e shows a closed system with similar functionality as the system ofFIG. 99 d. A first cylinder system 930 with a first cylinder 932 and afirst piston 931 is adapted to press a fluid through a first conduit 933to a valve 934. The valve is adapted to be operable to select conduitsto direct the force coming from the fluid pressurised by the firstcylinder system 930. The conduits are connected to several cylindersystems 936 adapted to receive the force from the first cylinder system930 and/or transmit force back to the first cylinder system 930. Thefirst cylinder system 930 could be adapted to be connected to anoperating device, as disclosed with reference to FIG. 37 for poweringthe system. By the function described with reference to FIG. 99 e afully implantable system is disclosed for transferring force from onelocation to several others using a selection valve 934.

FIG. 100 discloses an implantable heart help device similar to theembodiment disclosed with reference to FIG. 97 with the big differencethat the heart help device is operated totally hydraulic by a hydraulicsystem 519 b placed in the abdomen and in a connection with a conduit514 adapted to transfer force through an opening in the thoracicdiaphragm though a diaphragm contacting part 501 adapted to assist inthe maintaining of the opening in the thoracic diaphragm D. The conduittransfers force to a force entering section 517 adapted to transform thehydraulic force to mechanical force for exerting force on the heart H bythe arms 516 pivotally connected at a joint 515 to the heart contactingorgans 502 a,b. The hydraulic or pneumatic system 519 b could comprise ahydraulic or pneumatic pump creating the force. The system could bepowered or controlled non-invasively from outside the body.

FIG. 101 a-d shows an embodiment of the diaphragm contacting partdisclosed in several embodiments throughout the application. Thediaphragm contacting part of FIG. 101 a is a diaphragm contacting partadapted to be opened to enable the insertion of force transferringmembers or diaphragm passing parts. The diaphragm contacting partcomprises an outer section 509 which is adapted to engage the edges ofan opening created in the thoracic diaphragm. The edges 507 of thethoracic diaphragm could clamp the thoracic diaphragm and thereby assistin the fixation of the diaphragm contacting part to the thoracicdiaphragm and/or to the pericardium. The diaphragm contacting part couldbe closed by means of protrusions 510 in one part of the opening andrecesses 511 in the other part of the opening. The protrusions andrecesses match and thereby supply a mechanical fixation of the diaphragmcontacting part. FIG. 101 b shows the diaphragm contacting part possibleto open in its closed state. The inner surface 508 of the diaphragmcontacting part is smooth not to injure any force transferring member ordiaphragm passing part. The inner surface 508 could be made of a highlydurable material such as a ceramic material for better resisting thewear that direct contact with a force transferring part creates.

FIG. 101 c shows an embodiment of the diaphragm contacting part in whichthe diaphragm contacting part is a solid ring without the functionalityof being able to be opened. The diaphragm contacting part is similar toa grommet and has basically the same functionality. FIG. 101 d shows thesolid ring in section.

FIG. 102 shows the diaphragm contacting part in an embodiment when aforce transferring member 502 has been placed in the diaphragmcontacting part to enable the transfer of force from the abdominal saidof the thoracic diaphragm to the thoracic side of the thoracicdiaphragm.

FIG. 103 shows diaphragm contacting part in an embodiment where twoforce transferring members 502 a,b are placed in the diaphragmcontacting part, for transferring mechanical force from the abdominalside of the thoracic diaphragm to the thoracic side of the thoracicdiaphragm. According to the embodiment shown in FIG. 103 the forcetransferring member 502 b is adapted to transfer a translating orreciprocating force, whereas the force transferring member 502 a isadapted to transfer a rotating force.

FIG. 104 shows a force transferring member 502 placed in the diaphragmcontacting part, in an embodiment where the force transferring member502 is adapted to seal against the diaphragm contacting part 501 andthereby seal the abdominal cavity from the thoracic cavity, which isbeneficial since there could be difference in pressure between theabdominal cavity and the thoracic cavity. The seal is created in acontacting point 513. The surfaces of the contacting points 513 could bemade of a highly durable material for resisting the wear, such as aceramic material, for resisting the wear created by the constant contactbetween the diaphragm contacting part 501 and the force transferringmember 502.

FIG. 105 shows the diaphragm contacting part in an embodiment in which aconduit 514 is placed in the diaphragm contacting part for enabling thetransfer of hydraulic force from the abdominal side of the thoracicdiaphragm to the thoracic side of the thoracic diaphragm.

FIG. 106 shows the diaphragm contacting part in an embodiment where oneforce transferring member 502 for transferring mechanical force, and oneforce transferring member 514 for transferring hydraulic force is placedin the diaphragm contacting part.

FIG. 107 shows an embodiment in which the force transferring part 502 isplaced in the thoracic diaphragm D without the use of a diaphragmcontacting part 501. The force transferring part is thus adapted toassist in the maintaining of an opening in the thoracic diaphragm D. Theforce transferring member 502 could be adapted to be in contact with thethoracic diaphragm D when the force transferring member is placed in theopening in the thoracic diaphragm D and thereby transferring force fromthe abdominal cavity to the thoracic cavity while sliding against thethoracic diaphragm D.

FIG. 108 a shows an embodiment of a heart help device adapted to exert aforce on the heart. The heart help device comprises a fixation plate 242for enabling fixation of the device to a part of the human bodycomprising bone though screws being placed in the fixation holes 610 inthe plate 242. A magnetic operating device 600 is mounted onto the platefor operating the heart contacting organs 602 a,b adapted to exert aforce on the heart. According to some embodiments the heart contactingorgans 602 a,b are hydraulic or pneumatic cushions, the function thereofbeing described with reference to other figures herein. A first arm 616a connects the part comprising the operating device 600 to a hinged 604second arm 616 b which enables the movement of the second arm 616 b inrelation to the first arm 616 a. A first heart contacting organ 602 a isoperably mounted to a plate 615 adapted to enable movement of the firstheart contacting organ 602 a for changing the location of the forceexerted on the heart. The plate is operable by a gear connection 614;613between the plate 615 and a motor 612 adapted to operate the plate 615.The force exertion on the heart is performed by the operation device 600being in connection with a driving member performing an eccentricrotating movement of a fixation point 609 to which a driving wire 621 isfixated and thereby pulling of the second hinged arm 616, therebycreating the movement exerting force on the heart. The heart help deviceis by this construction periodically exerting force on the heart musclefollowing the heart contractions and adding force thereto.

FIG. 108 b shows the implantable heart help device in a second viewdisclosing the movement functionality adapted to alter the position ofthe heart help device and the heart contacting organs, thereby alteringthe position of the force exerted on the heart, from a first area of theheart to a second area of the heart. The operating device comprises afirst motor 605 adapted to affect a gear functionality 608 creating atranslating movement of the heart pump device in relation to thefixation plate 242. The implantable device further comprises a unit 607adapted to enable a rotating movement of the heart pump device inrelation to the fixation plate 242. For securing the position theoperating device further comprises a locking member 606 for locking theheart help device in a specific position for exerting force on theheart. The unit 607 further comprises the operating device adapted torotate the eccentrically rotating fixation point 609 pulling on theoperation wire 621 creating the force exerted on the heart. According tothis embodiment the arms are spring loaded by a spring 603 in anoutwards direction, which pulls the arms 616 a,b apart after theoperating wire 621 has pulled the arms 616 a,b together. The entiresystem could be adapted to be controlled non invasively from the outsideof the by, e.g. by means of a remote control. The system could then havesensor functionality for sending feedback on the location and operationsof the device to outside the body, for example by means of wirelesstransfer. It is also conceivable that scale 611 is made fromradiologically dense material thus enable the scale to be read on aradiological image.

FIG. 109 shows the operating device in further detail. The operatingdevice comprises a first part 640 having a first surface, and a secondpart 641 having a second surface, and a third part 642 having a thirdsurface. The second part is displaceable in relation to the second andthird part. The first, second and third surfaces are adapted to abuteach other, at least partially. The first part exerts indirectly forceon an external part of the heart by the connection with the drive wire621. The first, second and third surfaces are substantially parallel.The second part comprises magnets 15 and the first and third partscomprise coils 14 and the displacement of the second part is createdthrough successive energizing of the coils 14. The force from thedisplacement is transferred to the dive wire through a gear system 643,644 in connection with the eccentric drive member comprising theeccentrically rotating fixation member 609 in which the drive wire 621is fixated.

FIG. 110 shows the first part 640 comprising coils 14 when the secondplate has been removed, however the FIG. also shows the magnets 15 fromthe second plate, even though the second plate has been removed.

FIG. 111 shows an embodiment of heart help device in which the hearthelp device comprises two heart contacting organs 702 which are adaptedto exert a force on the anterior and posterior side of the heart H,respectively. The heart contacting organs 702 are pivotally arranged ina joint 712. One surface of the heart contacting organs 702 are incontact with an eccentrically rotating driving member 711 operated by anoperating device 710 by a connection with a first gear system 718, whichtransfers force from the operating device 710 to a force transferringmember 720 to a second gear system 714 in close connection to theeccentrically rotating member 711. The eccentrically rotating memberand/or the surface of the heart contacting organs contacting theeccentrically rotating driving member could be made of a durablematerial, such as a ceramic material, for resisting the wear created bythe constant connection of the eccentrically rotating member 711 withthe heart contacting organ. The pump device of the implantable hearthelp device is hinged to an arm 705 connected to a device 706 enablingthe movement of the heart pump device along a fixation plate 708comprising two fixation members 704 for fixating the fixation plate 708to a part of the human body comprising bone. The entire system could beadapted to be controlled non invasively from the outside of the by, e.g.by means of a remote control. The system could then have sensorfunctionality for sending feedback on the location and operations of thedevice to outside the body, for example by means of wireless transfer.

FIG. 112 a shows an embodiment of the heart help device similar to thedevice shown with reference to FIG. 111. However the device according toFIG. 11 a is adapted to enter the pericardium P from the abdomen in thearea of the thoracic diaphragm D to which the pericardium P rests and isfixated. This method of placement enables the placement of the devicewithout entering into the thorax of the patient, facilitating theprocedure. The device is fixated to a part of the human body comprisingbone through a fixation arm 742 which in turn supports an operationdevice 741 placed in the abdomen of the patient. The operation device741 transfers force through a force transferring member 740 connected toa linking part 710 to which two force transferring members 720 areattached. The device is adapted to travel through an opening in thethoracic diaphragm D being maintained by a diaphragm contacting part 501fixated to the thoracic diaphragm D and the pericardium P.

FIG. 112 b shows the device of FIG. 112 b in its unfolded state with theoperation device 741 fixated to the a fixation plate 708 by means of aconnecting arm 742 which according to this embodiment is operable bymeans of a position operation device 706 to alter the position of theheart help device in relation to the fixation plate 708. The features ofother embodiments such as the respiratory movement compensator, thepericardial drain and the fibrotic tissue movement structure disclosed,with reference to FIG. 97 b are of equal relevance and could be includedin the embodiments of FIGS. 112 a,b.

FIG. 113 shows a flow-chart of an operation method which could comprisethe steps of: 1) dissecting a part of the human body comprising bone and2) fixating a fixating member to the bone, such that the fixation memberis placed in contact with the connection arm. In one embodiment of thissurgical procedure the method further comprises the steps of 3) creatingan opening in the thoracic diaphragm and 4) inserting the connecting arminto the thorax through the opening in the thoracic diaphragm. Thisdiaphragm approach enables a surgeon to place a heart help device in thepericardium of thorax without opening the thorax. The method couldfurther comprise the step of placing an operation device in the abdomenof the patient, transferring force to through an opening in the thoracicdiaphragm and into the thorax for operating a hart help device placed inthorax.

Please note that in the detailed description above any embodiment orfeature of an embodiment as well as any method or step of a method couldbe combined in any way if such combination is not clearly contradictory.Please also note that the description in general should be seen asdescribing both an apparatus/device adapted to perform a method as wellas this method in itself.

1. A medical device for assisting in the maintaining of an openingcreated in the thoracic diaphragm, said medical device comprises adiaphragm contacting part adapted to be placed in contact with thethoracic diaphragm and thereby assist in the maintaining of the openingcreated in the thoracic diaphragm.
 2. The medical device according toclaim 1, wherein the diaphragm contacting part is adapted to assist inthe maintaining of the opening created in the thoracic diaphragm byengaging the edges of said opening.
 3. The medical device according toclaim 1, wherein the diaphragm contacting part is a grommet.
 4. Themedical device according to claim 1 wherein the diaphragm contactingpart is further adapted to be in contact with the pericardium andthereby also assisting in the maintaining of an opening in thepericardium.
 5. The medical device according to claim 1, wherein thediaphragm contacting part further comprises a fixation portion adaptedto assist in the fixation of said medical device to the thoracicdiaphragm.
 6. The medical device according to claim 5, wherein saidfixation portion is adapted to enable fixation of said medical device tothe thoracic diaphragm by sutures running through said fixation portion.7. The medical device according to claim 5, wherein said fixationportion is adapted to enable fixation of said medical device to thethoracic diaphragm by staples running through said fixation portion. 8.The medical device according to claim 5, wherein said fixation portionis adapted to enable fixation of said medical device to the thoracicdiaphragm by staples running in connection with said fixation portion.9. The medical device according to claim 5, wherein said medical devicefurther comprises a fixation member adapted to run through said fixationportion for enabling fixation of said medical device to the thoracicdiaphragm, said fixation member comprises a first portion adapted to beinserted from a first side of the thoracic diaphragm, through a part ofthe thoracic diaphragm, and to a second side of the thoracic diaphragm,and wherein said fixation member further comprises a second portionadapted to engage the thoracic diaphragm on the second side and therebylock said fixation member to the thoracic diaphragm.
 10. The medicaldevice according to claim 9, wherein said second portion is hinged tosaid first portion.
 11. The medical device according to claim 1, whereinsaid medical device further comprises a force transferring part, andwherein said force transferring part is, adapted to travel through theopening and transfer force between the abdominal side of the thoracicdiaphragm and the thoracic side of the thoracic diaphragm or thepericardium.
 12. The medical device according to claim 11, wherein saidforce transferring part comprises a mechanical element adapted totransfer mechanical force.
 13. The medical device according to claim 12,wherein said mechanical element is adapted to transfer at least one of arotating force and a translating force.
 14. The medical device accordingto claim 12, wherein said rotating force is an eccentrically rotatingforce.
 15. The medical device according to claim 11, wherein said forcetransferring part comprises a conduit adapted to transfer hydraulic orpneumatic force.
 16. The medical device according to claim 11, whereinsaid force transferring part comprises an electric lead adapted totransfer electric energy.
 17. The medical device according to claim 11,wherein said diaphragm contacting part is adapted to at least partlyencircle said force transferring part, when in use.
 18. The medicaldevice according to claim 11, wherein at least one of said diaphragmcontacting part and said force transferring part comprises ceramicmaterial.
 19. The medical device according to claim 18, wherein saiddiaphragm contacting part and said force transferring part are adaptedto contact each other in at least one contacting point, and wherein saidat least one contacting point comprises said ceramic material.
 20. Themedical device according to claim 17, wherein said diaphragm contactingpart and said force transferring part are adapted to seal against eachother, such that the thorax is sealed from the abdomen in the area ofthe diaphragm contacting part. 21.-99. (canceled)